Determinants of adverse pregnant outcomes in Mutare district clinics, By

Determinants of adverse pregnant outcomes in Mutare district clinics,  By
Determinants of adverse pregnant outcomes in Mutare district clinics,
Manicaland Province, Zimbabwe.
By
Blessmore Vimbai Chaibva
Student no: 12163733
A dissertation submitted in partial fulfilment of the requirements for the degree
Master of Public Health in the Faculty of Health Sciences
University of Pretoria
Pretoria
December 2014
Supervisor
Professor Andy Beke
Co-supervisors
Steve A.S Olorunju, Doctor Simon Nyadundu
Contact details
Cell: +263772666487
E-mail: [email protected] or [email protected]
Date: 15 October 2014
i
Declaration
I declare that the dissertation titled “Determinants of adverse pregnant outcomes
in Mutare district clinics, Manicaland Province, Zimbabwe.” which I hereby
submit for the degree Master of Public Health to the University of Pretoria is my own
original work and where other people’s work has been used, it has been properly
acknowledged and referenced. Neither this work, nor any part of it, has been
submitted to any other tertiary institution for any degree or diploma.
Full name of Student: Blessmore Vimbai Chaibva
Signed:
Date:
STUDENT
Full name of Supervisor: Professor Andy Beke
Signed:
Date:
SUPERVISOR
Full name of Co-supervisor: S.A.S Olorunju
Signed:
Date:
CO-SUPERVISOR
Full name of Co-supervisor: Doctor Simon Nyadundu
Signed:
Date:
CO-SUPERVISOR
ii
Acknowledgements
Firstly I would like to thank the Lord God Almighty for his blessings and mercy which
saw me embark on my Master of Public Health Degree at the University of Pretoria.
His grace has taken me this far, and without the guidance, wisdom and revelation
that comes from above I would not have managed. All glory be to the Most High
God: Yahweh.
Secondly, I would like to thank my supervisor Professor Andy Beke for the
continuous guidance throughout my studies. May your fountain of knowledge never
run dry. Professor Steven A. S. Olorunju, thank you for your statistical critic and
guidance throughout the conception and analysis of this project. May the good hand
of the Lord be upon you always. Dr Simon Nyadundu, thank you for your time,
valuable input, critical analysis throughout the research process. Thirdly my gratitude
goes to the staff at Sakubva maternity hospital for the continuous assistance
throughout the data collection process. Fourthly, the Provincial Medical DirectorManicaland staff, thank you for covering me up and your support is cherished all the
time.
My gratitude also goes to the Directorate of Pharmacy Services staff for your
encouragement throughout my studies. You were by my side, had confidence in me
even when I thought I could not achieve. Thank you
To my family, I salute you. Mom and dad sisters Tafadzwa, Rumbidzai, brother
Chenjerai you were there throughout the steps, praying for me and cheering me up.
Thank you for being the shoulder I would lean on, the rock and strength throughout. I
love you. To all my friends, thank you for your support.
Lastly but not least, thank you to my Pastors, Pastors Wilson and Nyarai Katumba,
for watching over me in your prayers throughout the journey.
May the hand of God be upon you all
Blessmore Vimbai Chaibva
iii
Dedication
This dissertation is a special dedication to all women who have seen themselves
through the nine months of joy, anxiety and expectation of an addition to their
families. This joy however is cut short at the end of the period after the baby has
been termed stillbirth or only a few days after giving birth they have to say goodbye
to a precious neonate who has just deceased. They ask many questions which
remain unanswered. I hope that the findings of this study will help in ensuring that
factors that can be addressed from the facility level are rectified so that women come
out of the hospital with joy unspeakable.
I also dedicate this work to my late grandfather, Hundivenga Munhanga, a man of
God who stood by me in prayer. Grandfather, your love, teachings will always be in
my heart. I know you were always in the prayer closet for me. I miss you and may
your soul rest in eternal peace. Your life here on earth was well spent and I celebrate
what God has done in my life through your teachings.
iv
Executive summary
Globally, neonatal mortality, and still births are major public health problems. Though
preventable, nearly three million babies die every year in their first month of life and a similar
number are stillborn, accounting for 7% of global burden of disease, which is higher than the
burden of Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome
(HIV/AIDS). Up to 50% of all deaths within the first month occur within the first 24 hours of
life, and up to 75% occur in the first week.
Zimbabwe’s Neonatal Mortality Rate (NMR) rose from 33/1000 deaths per 1000 live births
in 1990 to 39/1000 in 2012. The country is far from reaching Millennium Development Goal 4
(MDG4) on child survival as the pattern on rising NMR is evident in districts like Mutare.
Though interventions like result based financing (RBF), increase in midwifery training,
provision of Basic Emergency Obstetric and Neonatal Care (BEMNOC) have been
implemented in the district, the district has a high NMR of 55.2 deaths per 1000 live births.
This study aims to explore the determinants of adverse pregnancy outcomes in Mutare
facilities. The primary objective of the research is to determine if pregnancy outcomes differ
by socio-economic, maternal, neonatal, delivery and health system factors.
The study will employ a retrospective cross-section analytical approach. Records of pregnant
women who delivered at 7 sampled facilities during the period January 2014 to June 2014
will be reviewed. The working definition for adverse pregnancy outcomes for this study will be
women who had a fresh still birth or early neonatal deaths.
The results from the study will be presented as a report in partial fulfilment of the
requirements for the award of the degree on Master of Public Health by the University of
Pretoria. A presentation of the results will be made to the Health Executive of Mutare districts
as well as Manicaland Province. The results will also be published in a reputable journal and
availed for public consumption.
v
Table of Contents
Declaration .................................................................................................................. ii
Acknowledgements .................................................................................................... iii
Dedication .................................................................................................................. iv
Executive summary .................................................................................................... v
List of Figures............................................................................................................. 4
List of Tables .............................................................................................................. 4
List of Appendices ...................................................................................................... 5
PART ONE: RESEARCH PROTOCOL ..................................................................... 6
1.0 Introduction and literature review ...................................................................... 6
Background information ...................................................................................... 6
Definition and epidemiology of pregnancy outcomes ........................................................ 6
Global burden child mortality ............................................................................................ 7
Adverse pregnancy outcomes and burden to the health care ........................................ 8
Stillbirths and neonatal deaths .......................................................................................... 8
Risk factors/determinants of adverse pregnancy outcomes ................................... 9
Levels of prevention ......................................................................................................... 9
Literature review ................................................................................................. 10
Introduction .................................................................................................................. 10
Maternal programs in Mutare District ........................................................................... 11
Defining the research problem ..................................................................................... 12
Conceptual framework ................................................................................................. 13
Research problem........................................................................................................ 15
Research question ....................................................................................................... 15
Relevance of study ...................................................................................................... 15
2.0 Aims and objectives ........................................................................................ 15
1
Broad objective ............................................................................................................ 15
Specific objective ......................................................................................................... 15
3.0 Methods .......................................................................................................... 16
Study design ................................................................................................................ 16
Study variables ............................................................................................................ 16
Study setting ................................................................................................................ 17
Study population .......................................................................................................... 17
Sampling method ......................................................................................................... 18
Sample size calculation ............................................................................................... 18
Measurement ..................................................................................................... 18
4.0 Data Management and Analysis ..................................................................... 19
5.0 Ethical considerations ..................................................................................... 19
Permissions .................................................................................................... 19
6.0 Logistics and time schedule ............................................................................ 19
7.0 Budget/ resources ........................................................................................... 20
8.0 Reporting of results ......................................................................................... 20
9.0 References...................................................................................................... 21
PART TWO: JOURNAL ARTICLE .......................................................................... 29
2.1
Cover Letter ................................................................................................ 29
2.2 Manuscript ...................................................................................................... 30
Appendices .......................................................................................................... 46
2
List of acronyms
AIDS
Acquired Immunodeficiency Syndrome
ANC
Antenatal Care
APH
Antepartum Hemorrhage
BEMNOC
Basic Emergency Maternal Neonatal Obstetric Care
DHE
District Health Executive
DHIS
District Health Information System
ENND
Early Neonatal Death
HIV
Human Immunodeficiency Virus
ICD
International Classification Division
IMAI
Integrated Management of Adolescent and Adult Illness
IMPAC
Integrated Management of Pregnancy And Childbirth
IPTp
Intermittent Preventive Treatment of malaria in pregnancy
LBW
Low Birth Weight
MDG
Millennium Development Goal
MICS
Multiple Indicator Cluster Survey
MOHCC
Ministry of Health and Child Care
MRCZ
Medical Research Council of Zimbabwe
NMR
Neonatal Mortality Rate
NVD
Normal Vertex Delivery
PHE
Provincial Health Executive
PIH
Pregnancy Induced Hypertension
PMD
Provincial Medical Director
RBF
Result Based Financing
RTI
Reproductive Tract Infection
SSA
Sub-Saharan Africa
WHO
World Health Organization
ZDHS
Zimbabwe Demographic Health Survey
3
List of Figures
Figure 1: Definition of pregnancy outcomes: .............................................................. 7
Figure 2: Mosley and Chen Conceptual framework ............................................... 144
List of Tables
Table 1: Operational definitions and categorization of the variables.........................16
Table 2: Socio-demographic characteristics……………………………………………36
Table 3: Reproductive, maternal, neonatal, and health system characteristics.........37
Table 4: Bivariate analysis for Socio-demographic characteristics…………………..38
Table 5: Bivariate analysis for health care system factors………………………….....38
Table 6: Bivariate analysis for maternal, neonatal factors, reproductive…………….39
Table 7: Multivariable analysis..……………………………………………………….....40
4
List of Appendices
Appendix 1: Study Gantt Chart………………………………………………………27
Appendix 2: Estimated Study Budget……………………………………………….28
5
PART ONE: RESEARCH PROTOCOL
1.0 Introduction and literature review
Background information
Definition and epidemiology of pregnancy outcomes
Perinatal outcomes refer to life events that occur to a newborn infant from the age of
viability (28 weeks) and the first week of life.1 The transition of a fetus immersed in
amniotic fluid and totally dependent on placenta to a squalling air-breathing baby is a
source of wonder to the family.2 However the transitional process is not always
smooth and can result in adverse events to the mother or baby. Pregnancy
outcomes vary from pregnancy to pregnancy and can be: a healthy live baby, a low
birth weight baby (LBW), prematurity in the baby, a stillborn, intra-uterine fetal death,
early neonatal death and late neonatal death. Usually the health of the mother and
newborn are inseparable and the most severe adverse outcomes of pregnancy
include:- the death of the baby or the mother and in some cases both mother and
baby.
The ICD-10 (International Classification of Diseases 10th revision) classifies stillbirths
as a loss of a fetus ( ≥500g) from natural causes or a loss after the 22nd week of
pregnancy. Early neonatal deaths (ENND), is defined as deaths that occur within the
first seven days of life. Zimbabwe registers and captures fresh stillbirths, macerated
stillbirths and early neonatal deaths as pregnancy outcomes in District Health
Information System version 2 (DHIS2). Due to limited data, the working definition for
adverse pregnancy outcomes for this study includes fresh stillbirths and early
neonatal deaths.
Every pregnancy intends for a child, however tragic events to the affected mothers
and families like still births and neonatal deaths are common, especially in low and
middle income countries. Nearly, 3 million third trimester stillbirths occur every year
with low and middle-income countries bearing 98% of the burden.3 On the other
hand, a similar number of children die within the first 28 days of life. While still births
rates are less than 5 per 1000 live births in high income countries, these rates are at
6
least 25 deaths per 1000 live births in low and middle income countries. Of those
that die within the first month of life, almost 50% die within 24 hours and 75% within
first 7 days of life.4
The figure below highlights pregnancy outcomes.
Figure 1: Definition of pregnancy outcomes:
Defining stillbirths and associated pregnancy outcomes for international comparison: Definitions from
ICD, tenth revision. ICD=International Classification of Diseases. The Lancet 2011; 377:1448-1463
(DOI:10.1016/S0140-6736(10)62187-3
Global burden child mortality
Globally, under five mortality has reduced by 47% from 90 (CI 89, 92) deaths per
1000 live births in 1990 to 48 (CI 46, 51) in 2012.5 However, this is far from achieving
the MDG4 target of reducing under-5 mortality by two-thirds from the 1990 baseline.
Furthermore, there is wide variability in the rates of reduction in under-5 mortality
within regions and countries. While most regions have reduced under-5 mortality by
at least 50%,1 sub- Saharan Africa (SSA) rates of decline were 35%. 6
While under-five mortality is on the decline globally, there is an increase in deaths
during the neonatal period. The worlds neonatal mortality rate declined from 33
deaths per 1000 live births in 1990 to 21 in 2012, a 37% decline compared to a
7
decline from 90 to 48 deaths per 1000 live birth in under 5 mortality a 47% decline.
Consequently, the proportion of under-five deaths that occur within the first month of
life (the neonatal period) has increased 19 percent since 1990, from 37 percent to 44
percent, because declines in the neonatal mortality rate are slower than those in the
mortality rate for older children.5
Adverse pregnancy outcomes and burden to the health care
Measurement of maternal, infant and child outcomes are basic indicators of a
country’s socio-economic, and level of health care.7 Pregnancy monitoring from
antenatal care, delivery and postnatal requires a complete health system from
human resources, to governance and infrastructure. Because pregnancy
complications (ante- and intra- partum) are often unpredictable they require a timely,
rapid, skilled response and availability of tertiary obstetric services that are well
coordinated by a team of midwife, obstetrician and paediatrician. Poor coordination
of health activities, human and resources towards a pregnancy can result in adverse
outcomes, e.g. stillbirths, neonatal and maternal deaths.
Stillbirths and neonatal deaths
Stillbirths and neonatal mortality are pregnancy outcomes of public health concern.
Approximately 3 million8 stillbirths and a similar number of neonatal deaths are
recorded worldwide yearly with low and middle income countries contributing, 98% of
the cases. This accounts for about 7% of the global burden of disease, which is
greater than that contributed from vaccine preventable diseases and malaria.9
Regional and inter-country still births and neonatal mortality rate variations are quite
substantial. While, high income countries have a stillbirth rate of 4 deaths per 1000
live births, low and middle income countries have recorded nine times the rate. Intercountry variations have been recorded in Nigeria, where rural northern communities
of Nigeria recorded higher stillbirths compared to teaching hospitals in southern
Nigeria.10,11
Though stillbirths and neonatal mortality contribute greatly to child mortality, there is
low recognition of the problem by policy makers at national and international levels.
Outreach, family-community and facility based care when universally available have
been shown to avert a 42-75% 12 neonatal mortality worldwide yet the burden of
stillbirths and neonatal mortality is on the increase.
8
Risk factors/determinants of adverse pregnancy outcomes
Various factors which are of a public health concern have been shown to influence
pregnancy outcomes. These can be divided into four major groups that are: socioeconomic, maternal and health care factors.
The risk factors include:
Socio-demographic factors: maternal and paternal
education,13,14parity,15,16,17 gravidity, age of sexual debut, marital status,18 interpregnancy interval (IPI). 19-21
Maternal factors: age, 22-24maternal medical history (obesity and diabetes,
hypertension, HIV/AIDS),16,25,26 pre-pregnancy weight, reproductive tract infection,
malaria, smoking and alcohol consumption. 27
Previous pregnancy outcomes: previous spontaneous or induced abortion,28
Neonatal factors: sex of the neonate,29-31gestational age,16 birth weight, 5 minute
apgar score,
Socio-economic factors: parental occupation,32 household income,13 education
Health care factors
Delivery factors: mode of delivery,24,32 complications during delivery/ mother refereed
for delivery services,24,32 births attended by a trained birth attendant,33 place of
delivery,22,24,34 use of partograph, free delivery services.24
Pre-delivery factors: availability and use of ante-natal care (ANC) services- prenatal
care onset, frequency and timing of ANC, number of ANC visits,35-38 booking
status,39 drug taking or use of plants during pregnancy.40
Levels of prevention
The risk factors for pregnancy outcomes are multifactorial and only some of them are
preventable or treatable.16 Primary prevention of adverse outcomes include proper
nutrition for the woman to minimize maternal obesity a risk factor for adverse
pregnancy outcome, cessation of factors like smoking and alcohol consumption.
During the entire period of pregnancy, methods that can be used to prevent adverse
pregnancy outcomes are available. These include: immunization against tetanus
toxoid, folic-ferrous micronutrient supplementation, Intermittent Preventive Therapy
(IPTp) for malaria. Routine screening of and treatment of reproductive tract infections
(RTI), and syphilis can prevent adverse outcomes like preterm births. Identification
9
and early treatment of maternal malaria is important in prevention of severe
outcomes like maternal deaths and stillbirths.
In Zimbabwe, adverse pregnancy outcome prevention strategies are through a
continuum of care. These include; 4 focused antenatal visits for the pregnant
women, integrated management of adulthood illness/ integrated management of
pregnancy and childbirth (IMAI/IMPAC), deliveries assisted by skilled birth
attendances, postnatal care visits at day 3,7. The country has also embarked on
increased training of health workers in BEMNOC, training more midwives, building
waiting mother’s shelter to ensure that pregnant women can easily access
emergency services if need arises. Another strategy that has shown an increase in
health facility deliveries is removal of maternity user fees.
Literature review
Introduction
Globally, neonatal mortality is a major public health problem. Though preventable,
nearly three million babies die every year in their first month of life and a similar
number are stillborn. Within the first month, up to one half of all deaths occur within
the first 24 hours of life, and 75% occur in the first week.41 Neonatal mortality
accounts for 7% of the global burden of disease which is higher than the burden of
HIV/AIDS.
Sub-Saharan Africa has been termed the most dangerous continent for a baby to be
born. The regional neonatal mortality for 2012 was 32 deaths per 1000 live babies
contributing, 38% of global neonatal deaths. While 3 million neonates die globally, in
Nigeria alone 255 000 neonates die a year.42 The highest NMR, 66 deaths per 1000
live births, has been recorded in Liberia. Half of Africa’s 1.16 million neonate deaths
occur in just five countries – Nigeria, Democratic Republic of the Congo, Ethiopia,
United Republic of Tanzania and Uganda.
Zimbabwe, has a rising NMR and is far from reaching MDG4 on child survival. Since
1990 to 2012 the NMR has increased from 33 per 1000 live birth to 39 per 1000 live
births. According to the 2010/11 Zimbabwe Demographic Health Survey (ZDHS) the
infant mortality rate was 57 deaths per 1,000 live births while the overall under-5
mortality rate for the period is 84 deaths per 1,000 live births. Sixty-eight percent of
all deaths to children under-5 in Zimbabwe take place before a child’s first birthday,
with 37 percent occurring during the first month of life.43
10
The health structure in Zimbabwe is divided into primary, secondary, tertiary and
quaternary levels. Administratively, the hierarchy is from facility, district, provincial
and national level. For example, Mutare district is made up of 48 primary health
centres, one secondary health facility (Sakubva maternity hospital) and one tertiary
health facility (Mutare Provincial Hospital).
District mortalities have also shown an increasing perinatal mortality. Marondera, a
district in Mashonaland East, one of the ten provinces of Zimbabwe, recorded an
increase in perinatal mortality of 58.6/1000 and 64.6/1000 live births in 2007 and
2008 respectively.44 Mutare district recorded 534 (stillbirths + ENND) against 9673
(institutional live births) in 2013 which translated to 55.2 deaths per 1000 live births.45
Maternal programs in Mutare District
Mutare district, one of the seven districts in Manicaland is managed by local authority
(city), the government and rural district council. The city (local authority) has 9
primary health facilities and a population of 190 314 while district caters for 263 433
people. The expected births for Mutare City and district are 7900 and 10994
respectively.
Primary health care provision at the facilities includes general outpatient
consultation, HIV testing and counselling among others. Reproductive health
services include family planning services, antenatal care, delivery and postnatal
care. Only two of the city clinics provide basic emergency obstetric services BEMNOC and conduct deliveries while 44 of the facilities (includes 1 secondary and
1 tertiary institution- Mutare Provincial Hospital) provide BEMNOC.
Mutare district maternal services are subsidised through Results Based Financing
(RBF) since 2011. Provision of funds through the results based financing program in
Mutare district is set to improve the availability, accessibility and quality of key
reproductive and child health services and their optimum utilization. RBF means that
women can get maternal services at the facilities free of charge and the facility is refunded through the program (RBF).
Various indicators meant to improve maternal and child survival are being tracked
through RBF. Pregnancy indicators that are being monitored include antenatal care
visits, pregnant women screened for syphilis, delivery attended by skilled health
worker in health institutions and post natal care.
11
The theory of RBF is financing for results and is set to encourage managers to take
responsibility. Health facility managers are empowered to find solutions to solve
specific problems and they have the freedom to make decisions of how best to use
their revenue, which inputs to buy and from which independent supplier. For
example, some facilities decided to build waiting mothers homes as a means to
ensure that pregnant women are close to the health facility and basic obstetric care.
Despite all these interventions the district recorded a high number of stillbirths and
early neonatal deaths (55.2 deaths per live births).
RBF is also there to retain human resources for health. The staff receive 40% of the
cash pay-out made to the facility as part of staff individual performance bonuses for
results achieved. Though RBF was meant to improve the quality of services to
pregnant women and improve pregnancy outcomes, the district had a high number
of fresh stillbirths and early neonatal deaths (55.2/1000 deaths per live births) in
2013 which were mostly attributed to poor quality of services at the institutions.
Defining the research problem
Neonatal mortality remains a major contributor to death among children younger
than 5 years in Zimbabwe. While under 5 mortality rate rose from 74/1000 live birth
in 1990 to 90/1000 in 2012 the NMR increased from 31/1000 live births to 39/1000 in
2012. MICS 2014 showed a continued rising NMR trend from 20 deaths per 1000
live births in 2000 to 29 deaths per 1000 live births in 2014 The rising NMR in
Zimbabwe despite interventions is a cause for concern as the country is far off from
achieving MDG4 target of child survival.
The country embarked on various strategies which stretched throughout the
continuum of care from pre-natal to post natal care. In order to improve access to
pre-natal and delivery services by pregnant women, the country removed user fees.
Peer reviews of maternal and perinatal audits were introduced as a way to improve
the quality of antepartum services. Despite these efforts neonatal rates have been
on the increase.
Manicaland province recorded the highest number of perinatal deaths in the country
in 2013. According to DHIS2 data, the province recorded 1540 perinatal deaths,
against 44 610 (42 875 Institutional and 1735 home) deliveries. However, this could
be an underestimate due to the poor vital registry system.
12
DHIS2 data for the period January to June 2013, Manicaland province recorded 493
adverse pregnancy outcomes, against 20869 deliveries. Mutare district contributed
close to 40% of the adverse pregnancy outcomes. The district recorded 4690 births
out of expected births of 5497 and they also recorded 197 adverse pregnancy
outcomes (stillbirths and fresh neonatal deaths)
Despite existing interventions to curb perinatal mortality data on the determinants of
high perinatal mortality (adverse pregnancy outcomes) for the province and district is
scanty. This study set out to establish the determinants of adverse pregnancy
outcomes in Mutare district, and therefore recommend interventions that can be
adopted to improve pregnancy outcomes in the district.
Conceptual framework
The Mosley and Chen conceptual framework for the study of child survival in
developing countries was adapted, based on available data from the registers used
by the Ministry of Health and Child Care (MOHCC) in Zimbabwe. Figure 2 shows the
framework used in this study along with the selected possible predictors of neonatal
mortality in Zimbabwe.
13
SOCIO-ECONOMIC STATUS
-Residential area
-Maternal marital status
-Maternal religion
-Maternal/paternal education
-Parental occupation
-Household wealth index
-Paternal age when married
Maternal factor
-Age at birth
-Pre-obstetric
history
-Parity
-Gravidity
Neonatal factor
-Sex
-Birth size
-Birth interval
-Birth order/
rank
Pre-delivery
factor
-Desire for
pregnancy
-Number of ANC
visit
SURVIVE
Delivery factor
-Delivery assistance
-Delivery complications
-Mode of delivery
-Place of delivery
-Type of institution
Postdelivery
-Post natal
DIED
Figure 2: Mosley and Chen Conceptual framework
Conceptual framework for factors influencing pregnancy outcome adopted from Mosley and Chen
14
care
Research problem
Mutare district has a high proportion (55.2 deaths per 1000 live births) of adverse
pregnancy outcomes. High adverse pregnancy outcomes contribute to high infant
mortality which might result in the country failing to meet MDG4 target by 2015.
Research question
The research sought to establish the determinants of adverse pregnancy outcomes
in Mutare district so as to inform the district to target their interventions in order to
reduce the mortality.
Relevance of study
Maternity outcomes are indicative of the health care delivery system. A high rate of
adverse pregnancy outcomes reflects a poor health delivery system and is therefore
a public health concern. The study sought out to establish the determinants of
adverse pregnancy outcomes and therefore, inform the district on appropriate
strategies and interventions that can assist in reducing adverse pregnancy outcomes
and thereby improve the services offered by the district.
Aims and objectives
Broad objective
The study aimed to explore the determinants of adverse pregnancy outcomes in
Mutare district, Manicaland Province, Zimbabwe.
Specific objective
The study aimed to investigate if pregnancy outcomes differ by socio-economic
factors, maternal and neonatal factors, health system related and maternal medical
history. Specifically:
i.
Socio-economic factors (e.g. residential are, maternal education)
ii.
Maternal factors (e.g. maternal age, obstetric history)
iii.
Neonatal factors (e.g. sex, birth interval)
iv.
Maternal prenatal history (e.g. number of ANC visits )
v.
Delivery factors (e.g. birth attended by a skilled birth attendant)
vi.
Post-natal services provided
15
Methods
Study design
A retrospective analytical cross-sectional study review was employed. A review of
patient records of women who were attended at Mutare district facilities from January
2014 to June 2014 was done. Only relevant data was extracted for the study.
Operational definition for adverse pregnancy outcome included fresh still births and
early neonatal deaths.
Study variables
Study outcome definition: adverse pregnancy outcome referred to fresh still births
and early neonatal deaths. A fresh stillbirth was a neonate with no respiratory or
circulatory signs of life at birth after 28 weeks of gestation. Early neonatal mortality
included any death in the first 24 hours of life. In descriptive statistics neonatal
mortality was defined as the number of neonatal deaths per 1000 live births. The
explanatory variables included socio-economic and proximal determinants covering
maternal, neonatal, pre-pregnancy, pregnancy and post-pregnancy factors.
Table 1: Operational definitions and categorization of the variables
VARIABLE
DEFINITION AND CATEGORIZATION
SOCIOECONOMIC DETERMINANTS
Residential area
Residential area (1= urban 2= rural )
Maternal marital status
Marital status of mother (1=currently married 2= not
married)
Maternal religion
Maternal religion (1= Christian 2=Moslem 3=Apostolic, 4=
African Tradition )
Maternal education
Maternal years of schooling (as continuous variable)
Paternal occupation
Paternal years of schooling ( as continuous variable)
Paternal age when married
Paternal age when married (as a continuous variable
PROXIMAL DETERMINANTS
Maternal factors
Maternal age
Maternal age at childbirth (as a continuous variable)
Obstetric history
Obstetric history (1=previous Caesarean section
2=previous risk factors like eclampsia, haemorrhage, 3=previous stillbirth/neonatal death; 4=none)
Maternal medical history
Maternal medical history (1=non-HIV/AIDS; 2=HIV/AIDS,
3=HIV/AIDS plus non-HIV/AIDS, 4=none
Maternal malaria
Malaria during pregnancy (1=yes; 2=no)
Maternal syphllis
Syphllis test results during pregnancy (1=positive;
2=negative;3=not done)
16
Neonatal factors
Sex
Sex of neonate (1=female, 2=male)
Birth weight
Birth weight of neonate (grams)
Birth interval
Inter-pregnancy interval (number of years)
Parity
Parity (Integers)
Gravidity
Gravidity (Integers)
PRE-DELIVERY FACTORS
Number of ANC visits
Number of ANC visits (Integers)
Timing of ANC visits
Timing of ANC visits (1= according to WHO
recommendations, 2=not as WHO recommendations)
DELIVERY FACTORS
Delivery assistance
Birth attendance during delivery (1=skilled health
professional-midwife, obstetrician; 2=non-midwife health professional; 3=traditional birth
attendant/other)
Delivery complications
Complications during delivery (1=No; 2= Yes)
Mode of delivery
Mode of delivery (1=NVD, 2= caesarean section 3= breech)
POSTNATAL SERVICES
Post natal care
Post natal services received by neonate (1=no; 2=yes)
Study setting
The study was conducted at Sakubva Maternity Hospital, Mutare district, Zimbabwe.
The hospital receives referrals from the city and rural clinics.
Study population
Records of all pregnant women who were attended to at Sakubva maternity hospital
during the period January 2014 to June 2014 who met the inclusion criteria were
considered for the study.
Inclusion criteria:
Women who had singleton deliveries at Sakubva maternity hospital, Mutare District
during the period January to June 2014
•
Women whose age is 18 years and above
•
Women resident in Mutare District.
Exclusion criteria
17
•
Women aged less than 17 years
•
Women referred from other districts beside Mutare and referred from
other provinces
Sampling method
A random sample of the women who delivered in Mutare district was considered for
the study.
Sample size calculation
The Dobson’s formula was used to calculate the sample size
n = z 2 p (1-p)/Δ2
Where:
n = sample size
z = maximum allowable error risk
p = proportion of women who have adverse pregnancy outcomes
(1-p) = proportion of women who do not experience any adverse pregnancy
outcomes
And
Δ=absolute precision
Using a 95% confidence interval (z=1.96), Δ =0.05 and p= 0.18(where 18% of
women had an adverse pregnancy outcome)15
= (1.96)2
= 227
0.18 × 0.82
(0.05)2
Assuming a response rate of 80% (analogous to completeness of records)
n = (1/0.8) * 227
n = 283
the minimum sample which was required in the study is 300.
Measurement
Routine paper managed data from January to June 2014 was used in the study.
Records of women who were attended to at Sakubva maternity hospital from
18
January to June 2014 were used so as to ensure validity of the study. Missing data
was completed through calling the women via telephone.
Data Management and Analysis
Patient database in Mutare district is manual. Data, variables necessary for analysis
were extracted from manual registers, perinatal deaths forms to Excel. Data was
then imported to Stata 13 for analysis. The final analysis was under the guidance of
the mentors.
Descriptive statistics were computed for all variables. STATA 13.0 (Stata Corp,
College Station, TX) was used to summarize data, compare variables and test
hypotheses by generating means, frequencies, proportions, p-values and 95%
confidence intervals (CI).
Univariate and multivariable logistic regression was applied. The Univariate identified
individual factors that influence the outcome of measure (Survive or died).
Multivariate logistic regression was used to model the joint effects of all the factors
that influence pregnancy outcome. The problem of multiplicity was addressed.
Ethical considerations
Ethical approval for the study was obtained from the University of Pretoria Research
Ethics Committee and Medical Research Council of Zimbabwe (MRCZ).
No personal identifiers such as names and registration numbers of patients
appeared in the final report to ensure confidentiality and anonymity. Identification
(registration) numbers were used to aid in the analysis of data and as reference.
Only the researchers directly involved in this study had access to the data and only
for the purpose of this study.
No physical harm was inflicted since no human specimens were extracted from
participants.
Permissions
Permission to access records was obtained from the Provincial Medical Director:
Manicaland Province and the District Medical Officer Mutare District.
Logistics and time schedule
The Gantt chart attached in Appendix 1 shows the management of the project with
regards to time.
19
Budget/ resources
Appendix 2 shows and estimated budget of ZAR 21380.00 for the study which was
funded by the researcher.
Reporting of results
The findings of this study were presented as a research report in partial fulfilment of
the requirements for the award of the degree of Master of Public Health (MPH) at the
University of Pretoria. A copy of the report was also be presented to the Health
Executive of the District and Manicaland Province -DHE and PHE respectively.
The results were forwarded to a reputable journal for peer review and publication
and for general public.
Ms B. V. Chaibva was the first author and Prof Beke, Prof Olorunju and Dr
Nyadundu were second, third and fourth authors respectively.
20
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Diabetes as Risk Factors for Adverse Pregnancy Outcomes: Differences
Among 4 Racial/Ethnic Groups. Am J Public Health. 2005;95:1544–1551.
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27. Kramer MS, Séguin L, Lydon J, Goulet L. Socio-economic disparities in
pregnancy outcomes: why do the poor fare so poorly? Paediatric and
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28. Ouyang F, Zhang J, Betrán AP, Yang Z, Souza JP, Merialdi M. recurrence of
adverse perinatal outcomes in developing countries. Bulletin of the World
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DOI:http://dx.doi.org/10.2471/BLT.12.111021.
29. Tariq P, Kundi Z. Determinants of Neonatal Mortality. Department of
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30. Chaudhry MZ, Mustansar M, Chaudhry MY. Neonatal mortality in Pakistan. A
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31. Lagercrantz H, Katz Salmon M, Forssberg H. Neonatal mortality and morbidity
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32. Titaley CR, Dibley MJ, Agho K,Roberts CL, Hall J. Determinants of neonatal
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33. Parkhurst JO, Penn-Kekana L, Blaauw D, Balabanova D, Danishevski K,
Rahman SA, et al. Health systems factors influencing maternal health
services: a four-country comparison. Health Policy 2005;73:127–138.
34. de Jonge A, van der Goes B, Ravelli A, Amelink-Verburg M, Mol B, Nijhuis J,
et al. Perinatal mortality and morbidity in a nationwide cohort of 529 688 lowrisk planned home and hospital births. BJOG 2009;116:1177–1184.
35. Kramer MS. Determinants of low birth weight: methodological assessment
and meta-analysis. Bulletin of World Health Organization 1987;65:66.
36. Barros H, Tavares M, Rodrigues T. Role of prenatal care in preterm birth and
low birthweight in Portugal. Journal of Public Health Medicine 1996;18:321328.
37. Raatikainen K, Heiskanen N, Heinonen S. Under-attending free antenatal
care is associated with adverse pregnancy outcomes. BMC Public Health
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38. Nouaili EBH, Chaouachi S, Ayadi I, Said AB, Zouari B, Marrakchi Z. Risk
factors for perinatal mortality in a Tunisian population. International Journal of
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39. Kuti O, Orji EO, Ogunlola IO. Analysis of perinatal mortality in a Nigerian
teaching hospital. J Obstet Gynaecol 2003;23(5):512–4.
40. Sabiri N, Kabiri M, Karboubi L, Bouziane A, Barkat A. Risk factors for perinatal
mortality at Souissi Maternity Hospital, Rabat, Morocco. International
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2012 DOI:10.1016/j.ijgo.2012.07.004.
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41. World Health Organization [Internet]. Children: reducing mortality, fact sheet
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42. Partnership for maternal, newborn and child health [Internet]. Opportunities
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44. Tachiweyika E,Gombe N, Shambira G, Chadambuka A, Tshimamga M,
Zizhou S. Determinants of perinatal mortality in Marondera district,
Mashonaland East Province of Zimbabwe, 2009: a case control study. Pan
African Med Journal. 2011;8:7.
45. Zimbabwe District Health Information System2 [Internet]. 2014 [cited 2014
June 25]. Available from http://www.dhis.mohcc.gov.zw/dhis-webvisualizer/index.action.
26
Appendix 1: Study Gantt Chart
Activity
June
July
Final draft of protocol
Presentation to UP Research Ethics
Committee
Approval from UP REC
Presentation to Medical Research Council of
Zimbabwe MRCZ
Approval from MRCZ
Permission from PMD
Preparation for data collection
Data collection and entry
Preparation for data analysis
Data analysis
First draft of final report
Final draft of report
27
August
Sept
Oct
Appendix 2: Estimated Study Budget / Resources
Unit Cost
Total Cost
(ZAR)
(ZAR)
Copies
40
280
2
CDs
50
100
Research report Paper
4
Copies
250
1000
Questionnaire – codebook
1000
Copies
2
2000
Toner
1
Containers
600
600
Budget Item
Quantity
Units
Research protocol (7 copies)
7
Research report
Photocopying and Printing
Miscellaneous
2000
Sub-Total
7180
Communication
Internet and communication
5
External hard drive & USB
2
Months
500
2500
900
1800
Sub-Total
4300
Data Collection
Travel to and from site
10
Travel- South Africa and Zimbabwe
2
Days
150
1500
4000
8000
Sub-Total
9500
Dissemination of data
Posters
2
GRAND TOTAL
800
1600
21380
28
0
PART TWO: JOURNAL ARTICLE
1
2.1
2
3
4
5
6
7
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9
10
11
12
13
14
15
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Cover Letter
Faculty of Health Sciences
School of Health systems and Public Health
HW Snyman Building (North)
31 Bophelo Road
Gezina
Pretoria
16th December 2014
The Editor
BMC Pregnancy and Childbirth
REF: SUBMISSION OF MANUSCRIPT
Dear Sir/Madam,
17
Please find attached our manuscript entitled “Determinants of adverse pregnant
18
outcomes in Mutare district Clinics, Manicaland Province, Zimbabwe” by
19
Chaibva B V, Beke A, Olorunju SAS and Nyadundu S, a research article for
20
consideration for publication in your journal.
21
22
We believe the results presented in the manuscript provide insight into the
23
development of appropriate strategies and interventions to help to reduce stillbirths
24
and neonatal deaths and contribute to lower mortality among under five children.
25
26
All authors listed have approved the manuscript and declared no competing
27
interests. We declare that this manuscript has not been published in any scientific
28
journal or meeting and is not being considered for publication by another journal.
29
30
Thank you for your consideration. Please address all correspondence to me by e-
31
mail: [email protected]
32
33
Yours sincerely,
34
35
Blessmore V Chaibva
36
29
37
2.2 Manuscript
38
39
Determinants of adverse pregnant outcomes in Mutare district clinics,
40
Manicaland Province, Zimbabwe.
41
Blessmore V Chaibva1*, Andy Beke1 , Steve AS Olorunju2, Simon Nyadundu3
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*Correspondence: [email protected]
1. School of Health Systems and Public Health, HW,
Synman Building (North), 31 Bophelo Road, Gezina,
Pretoria, Faculty of Health Sciences, University of Pretoria,
South Africa
Full list of author information is available at end of article
76
77
30
78
Abstract
79
Background: Perinatal deaths are adverse pregnancy outcomes that account for
80
about 7% of global burden of disease, with developing countries contributing about
81
98% of deaths. This study aimed at determining the factors associated with adverse
82
pregnancy outcomes among women at Sakubva hospital, Mutare district, Zimbabwe
83
from January to June 2014.
84
Methods: A retrospective review of 346 patient records, of women who delivered at
85
Sakubva hospital and those referred from Mutare district facilities to Mutare
86
Provincial Hospital, between January and June 2014. Multilevel logistic regression
87
using a backward hierarchical approach was performed to compare twenty-four
88
variables associated with outcome. Variables with more than 80% data available
89
were considered for analysis. Stata 12.0 was used to analyse the data.
90
Results: Of the 346 women included in this study, 54 (15.61%) experienced an
91
adverse pregnancy outcome (stillbirth or early neonatal death). Delivery by non-
92
normal vertex method (caesarean section or breech presentation) has a four times
93
odds of adverse pregnancy outcomes compared to those who delivered a cephalic
94
presentation by normal vertex delivery (OR= 4.26; p<0.001). Experiencing
95
pregnancy associated complications has a 5 times risk of an adverse pregnancy
96
outcome compared to no complications (OR=5.85; p<0.001). Neonatal birth weight
97
of less than 2500grams was marginally significantly (OR = 2.48; p=0.053) associated
98
with adverse pregnancy outcome.
99
Conclusions: Clearly, the determinants of adverse pregnancy outcomes in Mutare
100
are; non-normal vertex delivery methods, complications during pregnancy/birth and
101
low birth weight (<2500grams). Firstly, identification of complications and breech
102
presentation during the third trimester by midwifes should be recognised as high risk
103
and these are to be monitored closely or referred to gynaecologist for assistance.
104
Secondly, management of low birth weight neonates has proven interventions which
105
include special baby care unit and kangaroo care which Sakubva could implement to
106
improve survival of these neonates. Lastly, further research is critical to identify the
107
root cause of association of method of delivery (caesarean section) and adverse
108
pregnancy outcomes.
109
110
Key words: Perinatal deaths, adverse pregnancy outcomes, Mutare district, stillbirth
31
111
112
113
Background
114
number of children die within the first 28 days of life.1, 2 These account for
115
approximately 7% of global burden of disease which is higher than that from
116
HIV/AIDS.3 Low and middle-income countries bear 98% of the burden with sub-
117
Saharan Africa reporting the highest burden globally.4, 5 In sub-Saharan Africa about
118
14% of all births could result in stillbirths.6 Most deaths (43%) among the under-fives
119
occur within the first month of life (the neonatal period).7
Worldwide, nearly 3 million third trimester stillbirths occur every year and a similar
120
Zimbabwe’s 2010/11 Demographic Health Survey (ZDHS) reported an infant
121
mortality rate of 57 deaths per 1,000 live births while the overall under-5 mortality
122
rate for the period was 84 deaths per 1,000 live births. There has been an increase
123
in neonatal mortality ratio (NMR) from 33 to 39 deaths per 1000 live births from 1990
124
to 2012.8 Zimbabwe Multiple Indicator Cluster Survey (MICS) 2014 also showed an
125
upward trend in NMR from 20 deaths per 1000 live births in 2000 to 29 deaths per
126
1000 live births in 2014.9 The rising NMR in Zimbabwe is occurring despite the
127
various interventions that include: subsidising maternal services through Results
128
Based Financing (RBF) which has resulted in removal of direct user fees. Peer
129
reviews of maternal and perinatal audits were introduced as a way to improve the
130
quality of services throughout the management of pregnancy. These efforts may be
131
contributing factors towards the overall downward trend in under-five mortality.9
132
However, Zimbabwe is far off from achieving the Millennium Development Goal 4
133
(MDG4) target of child survival due to the increasing neonatal mortality despite an
134
overall decrease in under 5 mortality. Therefore an understanding of the risk factors
135
and determinants of neonatal deaths would assist in addressing child survival
136
challenges.10
137
Risk factors that have been shown to influence adverse pregnancy outcomes, like
138
neonatal deaths, can be categorized into socio-demographic factors,11-17 maternal
139
factors,18-21 previous pregnancy outcomes,22 neonatal factors,23 socio-economic and
140
health system related factors.24-30 There is sparse data on the prevalence and
141
determinants of adverse pregnancy outcomes in sub-Saharan Africa.
142
This study’s operational definition for adverse pregnancy outcome included fresh
143
and macerated still births and early neonatal deaths. The study aimed to identify the
144
risk factors for adverse pregnancy outcomes in Mutare district, Zimbabwe.
32
145
Identification of risk factors for adverse pregnancy outcomes may contribute to
146
reduction in infant mortality by ascertaining factors that can be modified by
147
appropriate public health interventions.
148
Methods
149
Study design and setting
150
Mutare district population is served by a network of health facilities: primary,
151
secondary and tertiary health centres. The study area was Sakubva and Mutare
152
Provincial Hospital in Manicaland Province, Zimbabwe. The hospitals manage clients
153
from Mutare’s urban and rural population. Sakubva hospital receives and manages
154
clients from the rural and city primary facilities. It also, refers clients to Mutare
155
Provincial Hospital a tertiary institution. All referrals from Sakubva were followed up
156
at Mutare Provincial Hospital and considered as part of the study.
157
A retrospective cross-sectional analysis was done on the “delivery register” of
158
childbirths in Mutare district, from the period January 1st to June 30th, 2014. Other
159
records used were patient’s admission notes and antenatal (ANC) registers. All
160
women who met the inclusion criteria and delivered within the period January to
161
June 2014 were eligible to participate. For each birth record, information on socio-
162
demographics, maternal factors like previous obstetric history, neonatal information
163
(sex, birth-weight) and delivery factors which included attendance by a skilled health
164
worker, mode of delivery) and post natal factors were extracted.
165
The main outcomes examined in this study were stillbirths and early neonatal
166
deaths. Stillbirth was defined in accordance with World Health Organisation-agreed
167
definition of stillbirth for international comparison as death of a fetus weighing at
168
least 500 g or after 22 completed weeks of gestation occurring before the complete
169
expulsion or extraction from its mother [ICD-10]. Early neonatal death was defined,
170
for the purposes of this study, as death that occurred within the first seven days of
171
life.
172
Data from registers was double entered into Excel, cleaned and transferred to
173
Stata 12.0 (Stata Corp, Texas, and USA) for analysis. Descriptive statistics was used
174
to analyse categorical data.
175
176
Chi2 tests were used for univariable comparisons of dichotomous data to measure
association between outcome and variable data (more than five observation
33
177
expected in all cells) or Fisher’s exact test (five or fewer expected observations in
178
one or more cells).
179
Mantel- Haenszel test of homogeneity was used to establish effect modification or
180
confounding among variables. Univariable analysis was performed to examine the
181
association of each variable with adverse pregnancy outcome. Factors significant at
182
p = 0.0531 were considered into multivariate logistic. Multivariate regression was
183
modelled using the backward stepwise approach. Evaluation of the model was done
184
using the Pearsons GOF, ROC curve analysis. Effects of outliers was analysed
185
using the m-asymptotic residuals method. The model was checked for statistical
186
interactions and adequacy before being approved as final. The p values for all
187
hypothesis tests were two-sided and significance was set at p<0.05.
188
Ethical approval
189
The ethical clearance was granted by the University of Pretoria, Faculty of Health
190
Sciences Research Ethics Committee as well as the Medical and Research Council
191
of Zimbabwe. Permission to conduct and access patient records was obtained from
192
the Provincial Medical Directorate, Manicaland Province and the District Medical
193
Office, Mutare District Zimbabwe. Confidentiality of records was adhered to and
194
there were no personal identifiers used in the final report.
195
Results and discussion
196
The total number of records sampled was 427 of which 81 were discarded due to
197
more than 80% of the data being missing. Of the discarded records, 3.2% had an
198
adverse pregnancy outcome, 8.6% had complications and 6.2% had delivered by
199
non-vertex delivery methods. Three hundred and forty six records were then
200
analysed. The study was limited to Sakubva and Mutare Provincial hospitals due to
201
logistical challenges. Of the 346 records sampled 54 (15.61%) records had an
202
adverse pregnancy outcome (stillbirth or neonatal death) while 292 (84.39%) where
203
live births.
204
Background and characteristics of participants
205
The age of the women in the study ranged from 17 to 43 with a mean age of 26
206
(SD: 6.42). Seventy two percent (72.43%) were aged between 20-34 years old and
207
13.78% were 35 years old and above. Majority of the women (62.10%) in the study
208
sample attended to at Sakubva or referred to Mutare Provincial hospital (from
209
Sakubva hospital) resided in urban areas, while 37.90% were resident from rural
34
210
areas and was mostly referred for maternal services. The majority of the women
211
sampled (97.92%) were currently married while 2.08% were separated, divorced or
212
single. Close to 98% of the study population were Christians (either Pentecostal or
213
orthodox, apostolic sect), 1.38% Moslem and 0.46% belonged to the African
214
Tradition religion. Though the data on education was minimal (maternal education
215
n=73) it showed that education among the women was widespread with none of the
216
women having had no form of education. Twenty two percent of the women had
217
some form of primary education and more than 60% secondary education. Of the
218
346 women sampled only 12.7% were formally employed as teachers, cashier or
219
nurse aide while 87.3% were involved in informal trading or were housewives.
220
Paternal variables were not analysed due to unavailability of data.
221
Reproductive health characteristics
222
In terms of reproductive health characteristics, 67% had no history of previous
223
complications while 33% had experienced a complication like stillbirth, neonatal
224
death or abortion. Delivery by caesarean section in the previous pregnancy was
225
recorded as previous complications. Also, 15% of the women sampled were HIV
226
positive while 2% of the women had non-HIV chronic conditions like hypertension,
227
asthma, and psychosis prior to pregnancy. Approximately 8% of the women had an
228
episode of malaria (n=64) and 3% had tested positive for syphilis (n=34) during the
229
duration of the pregnancy. The median parity and gravidity were 1 and 2
230
respectively. The inter-pregnancy interval between the delivery under review and the
231
previous births was analysed with a median interval of 4 (IQR 2-7).
232
Neonate demographics
233
Approximately, fifty one percent of the neonates were female and 49% male. The
234
interquartile weight range for the neonates was 2700 to 3400 grams with a mean
235
weight of 3000g (SD= 599.26). The mean gestation age of the women was 37 weeks
236
while the minimum and maximum were 24 and 43 respectively.
237
Delivery factors
238
The study was conducted at Sakubva hospital, due to the many referrals occurring
239
from primary health care centres to Sakubva. Referrals out from Sakubva where
240
followed up at Mutare Provincial hospital and therefore included in the study. Most of
241
the adverse pregnancy outcomes in the district occur at the two hospitals. Seventy
242
six percent of the women had a normal vertex delivery (NVD), 18%, caesarean
35
243
section and 5% breech presentation deliveries. Of these deliveries 63% experienced
244
pregnancy associated complications like pregnancy induced hypertension (PIH),
245
prolonged labour and foetal distress. Majority of deliveries (94%) were attended to by
246
a skilled health professional, midwife or doctor and the rest by non-skilled
247
professional. Skilled professional was defined as either a midwife or doctor as this
248
could be identified from the register.
249
250
251
Table 2: Socio-demographic characteristics of women delivering at Sakubva hospital, January
to June 2014.
Variable
N (%)
%
95% Confidence interval
Residential area
Urban
Rural
n=343
213
130
62.10
37.90
0.57 – 0.67
0.33 – 0.43
Marital status
Not married
Married
n= 288
6
282
2.08
97.92
0.004 – 0.037
0.96 – 1.00
Maternal religion
Non-Apostolic
Apostolic
n=217
144
73
66.36
33.64
0.60 -0.73
0.27 – 0.40
252
p<0.05
253
Descriptive statistics was divided into:
254
Table 2: Socio-demographics
255
Table 3: Reproductive, maternal, neonatal and health system factors
256
257
The majority of the patients (88.15%) delivered at Sakubva hospital a secondary
258
level facility while 11.85 were referred to Mutare Provincial Hospital, a tertiary level
259
hospital for further management. Reasons for referrals included, complications of
260
pregnancy, need for blood transfusion among others. Non- normal vertex delivery
261
(NVD) in this study was categorised as caesarean section deliveries for various
262
reasons (including breech) or delivery of a breech presentation (termed breech
263
delivery).
264
265
266
267
36
268
269
Table 3: Reproductive, maternal, neonatal, and health system characteristics of women
delivering at SDH, January- June 2014.
Variable
N (%)
%
95% Confidence
interval
Maternal age
<20
20-34
35 +
n= 341
47
247
47
13.78
72.43
13.78
0.10 - 0.17
0.68 – 0.77
0.10 – 0.17
Obstetric history
None
Present
n= 282
190
92
67.38
32.62
0.62 – 0.73
0.27 – 0.38
HIV status
Negative
Positive
n= 303
257
46
84.82
15.18
0.81 -- 0.89
0.11 – 0.19
Neonatal sex
Male
Female
n = 333
166
167
49.85
50.15
0.44 – 0.55
0.45 – 0.56
Birth weight
<2500g
2500 – 4000g
4000+
n= 322
47
269
6
14.60
83.54
1.86
0.11 – 0.18
0.79 – 0.88
0.004 – 0.033
Gestational age
≥32
<32
n =316
303
13
95.89
4.11
0.94 – 0.98
0.02 – 0.06
Parity
n=334
109
195
30
32.63
58.38
8.98
0.28 – 0.38
0.53 – 0.64
0.06 – 0.12
Gravidity
<4
≥4
n= 333
260
73
78.08
2.92
0.74 – 0.83
0.17 – 0.26
Birth attendant
Unskilled
Skilled
n= 337
18
319
5.34
94.66
0.03 – 0.08
0.92 – 0.97
Delivery complications
None
Present
n= 334
121
213
36.23
63.77
0.31 – 0.41
0.59 – 0.69
Delivery method
NVD
Non - NVD
n = 338
260
78
76.92
23.08
0.72 – 0.81
0.19 – 0.28
0
1-3
4+
270
p<0.05
271
NB: unskilled referred to any professionals who are not a doctor or midwife.
272
273
37
274
Test of association
275
An analysis of the association of variables using the chi square test and Fischer’s
276
exact test showed significant association of some maternal, neonatal, reproductive
277
and health system factors while none of the socio-demographic factors were
278
significantly associated.
279
Logistic regression
280
The variables were analysed after grouping them into three broad categories: A
281
socio-demographics, B: maternal (pre, intra, post-partum period) pre-pregnancy and
282
delivery factors and C, neonatal and child related factors.
283
284
285
Table 4: Bivariate analysis (Crude Odds Ratio) for Socio-demographic characteristics
associated with adverse outcomes among women who delivered at SDH, January – June 2014.
Variable
Crude OR
p-value
95% CI
Residential area
Urban
Rural
Reference
0.90
Marital status
Married
Not married
Reference
1
Maternal religion
Non Apostolic
Apostolic
Reference
1.40
0.708
0.49 – 1.66
0.347
0.69 – 2.85
286
P<0.05
287
All the socio-demographic factors were not significant on binary logistic analysis.
288
289
290
291
Table 5: Bivariate analysis for health care system factors associated with adverse outcomes
among women who delivered at SDH, January- June 2014
Variable
Crude OR
p-value
95% CI
Birth attendant
Skilled
Unskilled
Reference
0.66
0.583
0.15 –2.94
Delivery method
NVD
Non- NVD
Reference
5.26
0.000
2.83-9.78
Reference
3.78
0.001
1.72 – 8.33
Delivery complications
None
Present
p<0.05
38
292
Health facility type was not analysed due to the difference in levels of care between
293
the two facilities. Tertiary level facilities manage patients that have been referred by
294
secondary level while secondary manages those referred by primary level. Health
295
system factors that were significantly associated with adverse pregnancy outcome
296
on bivariate analysis are: none normal vertex delivery (OR = 5.26; 95% CI: 2.83 –
297
9.78) and delivery complications (OR= 3.78; 95%CI: 1.72- 8.33). Birth attendant was
298
not significant.
299
300
Table 6: Bivariate analysis for maternal, neonatal factors, reproductive
Variable
Crude OR
p-value
95% CI
Maternal age
20-34
<20
35+
Reference
0.33
1.16
0.076
0.722
0.10 – 1.12
0.52 – 2.57
Obstetric history (poor)
None
Present
Reference
0.74
0.385
0.38 – 1.45
HIV status
Negative
Positive
Reference
0.79
0.616
0.31 – 1.98
Neonatal sex
Female
Male
Reference
1.34
0.346
0.73 – 2.45
Neonatal birth weight
2500 - 4000
<2500
4000+
Reference
3.73
3.98
0.000
0.119
1.82 – 7.68
0.70 – 22.68
Gestational age
≥32
<32
Reference
10.22
0.000
3.19 – 32.77
Reference
0.95
2.56
0.886
0.036
0.48 – 1.87
1.06 – 6.15
Reference
1.69
0.115
0.88 – 3.26
Parity
1-3
0 (nulliparous)
≥4
301
Gravidity
<4
≥4
p<0.05
302
Maternal age and HIV status were not significantly associated with adverse
303
pregnancy outcomes on bivariate analysis. Neonatal factors significantly associated
304
with adverse pregnancy outcome were gestation age less than 32 weeks (OR=
39
305
10.22; 95%CI: 3.19 –32.77) and birth weight less than 2500 grams (OR= 3.73, 95%
306
CI 1.82 – 7.68). Parity and gravidity were not significant.
307
Hierarchical backwards approach was employed in multivariable logistic regression
308
309
Table 7: Multivariable analysis of factors associated with adverse pregnancy outcomes.
Variable
OR
95% CI
p-value
Delivery method
NVD
Non-NVD
Reference
4.24
2.02 – 8.92
0.000
Complications during pregnancy
None
Present
Reference
6.04
1.90 – 19.22
0.002
Neonatal birth weight
2500 – 4000
<2500
Reference
2.48
0.99 – 6.19
0.053
Gestational age
≥ 32 weeks
< 32 weeks
Reference
3.89
0.83 – 18.21
0.084
Reference
2.89
0.88 – 9.50
0.080
Parity
1-3
≥4
310
p<0.05
311
312
Variables that were independently associated with adverse pregnancy outcomes in
313
our study were, other delivery methods that were not NVD (OR= 4.24; 95%CI 2.02 –
314
8.92), presence of complications during delivery (OR= 6.04; 95% CI; 1.90 – 19.22).
315
Neonatal birth weight less than 2500g was marginally significant (OR: 2.48 p=0.053)
316
Women who delivered a baby by other methods not normal vertex delivery section
317
were 4.2 times more likely to experience an adverse pregnancy outcome (stillbirth or
318
neonatal death) than those who delivered by normal vertex delivery. Also,
319
experiencing complications like PIH, eclampsia during pregnancy/delivery had close
320
to 6 times risk of an adverse pregnancy outcome compared to no complications.
321
Lastly, the odds of a perinatal death were 2 times more on a neonate delivered
322
weighing less than 2500g compared to a neonate of weight greater than 2500g.
323
Post regression tests carried out showed a ROC curve area of 0.80 indicating good
324
predictive power of the model. There was good agreement between the model
325
estimates/ predictions and the observed risks of adverse pregnancy outcomes in the
40
326
population. Analysis of the m-asymptotic residuals revealed that there were no
327
model outliers influencing the parameter estimates unduly. Therefore the model was
328
valid in estimating the risk factors for adverse pregnancy outcomes from socio-
329
demographic, maternal and neonatal & child variables.
330
Discussion
331
Our study has shown that the prevalence of adverse pregnancy outcomes
332
(stillbirths and early neonatal deaths) at Sakubva hospital in Mutare district for the
333
period January to June 2014 was 15.61%. Method of delivery other than normal-
334
vertex-delivery of cephalic presentation (i.e. caesarean section or breech
335
presentation) and presents of complications during pregnancy/delivery (e.g.
336
eclampsia, pregnancy induced hypertension) are important independent predictors of
337
adverse pregnancy outcomes in Mutare district. Neonatal birth weight of
338
<2500grams was marginally significant as a factor associated with adverse
339
pregnancy outcome.
340
The observed adverse pregnancy outcome prevalence rate of 15.6% is
341
comparable to other study findings conducted within the region.19, 31 High neonatal
342
mortality have been recorded in sub-Saharan Africa, Asia and Latin America, where
343
about 25% of stillbirths are most likely to result from complications of birth.32 In
344
Tanzania, 13 the prevalence of stillbirths and intra-uterine deaths was reported as
345
18% while Nigeria20 reported a 7.9% prevalence of perinatal deaths. In addition,
346
South Africa has a 13% prevalence rate of adverse pregnancy outcomes.33 The
347
factors contributing to this high prevalence in low-to-medium countries in Africa are
348
varying from human resources, nutrition and health systems. Shortages of an
349
appropriate number of well performing health workers, (human resources for health),
350
shortages of essential medicines, supplies and equipment34 could be possible
351
reasons for high prevalence of adverse outcomes in Mutare. Other possible factors
352
include, poor nutritional status, lack of antenatal care and a number of behaviours
353
which are associated with low-socioeconomic status.35 Health system factors that
354
might contribute to high prevalence of pregnancy outcomes include geographical
355
barriers to health care (distance to nearest health facility), user fees and health care
356
worker attitudes.36
357
The independent predictors of adverse pregnancy outcomes identified in this study
358
have been previously documented. There was a strong association between method
41
359
of delivery other than normal vertex delivery of a cephalic presentation (breech
360
presentation delivery or caesarean section) and adverse pregnancy outcomes.
361
Other studies have shown an increased risk of neonatal mortality and morbidity
362
with delivery by either elective or emergency caesarean section,37,38, 39 and delivery
363
of a breech presentation by vaginal method.40 It is common in our low-resource
364
setting for caesarean section to be instituted after prolonged and unsuccessful
365
vaginal delivery which might increase the risk of adverse outcomes.41 Adverse
366
pregnancy outcomes association with caesarean section delivery could also be due
367
to the fact that many caesarean sections have been performed as emergencies
368
without proper preparations.42 Also; caesarean section delivery has been associated
369
with risks of pre-rupture of membranes and therefore contributes to the high perinatal
370
deaths. Morbidity associated with caesarean section delivery is higher as the
371
neonates require more oxygen compared to NVD.
372
Firstly, method of delivery (vaginal delivery of breech presentation, emergency or
373
elective C/S) has been shown to contribute to outcomes that undermine early
374
childhood development of the newborn.42 High adverse outcomes in vaginal delivery
375
of a breech presentation have been associated with complications such as cord
376
prolapse, aspiration of amniotic fluid, and complications associated with difficulties of
377
delivering the after-coming resulting in greater risk among vaginal delivery in breech
378
presentation compared with vaginal delivery in cephalic presentation.43The
379
caesarean section rate at Sakubva maternity hospital was 238 deliveries by
380
caesarean section out of total deliveries of 1732 during the period, January to June
381
2014,44 which might be due to a high referral rate from other facilities.
382
On another hand, caesarean section delivery, when appropriately instituted has
383
been shown to be protective of perinatal deaths.39 Good caesarean delivery
384
practices require technical, appropriate and timely decision-making to produce
385
favourable results. However these aspects of caesarean section delivery were not
386
established in this study. Caesarean section challenges that contribute to adverse
387
outcomes could occur before, during and after the surgical procedure. The current
388
study however could not establish the timing of caesarean section from the registers.
389
Therefore, this finding is difficult to interpret and calls for further studies to
390
understand the root cause of delivery method being associated with adverse
391
pregnancy outcomes.
42
392
Secondly, women who experienced complications (cord prolapse, mal-
393
presentation, antepartum haemorrhage (APH), eclampsia, prolonged labour, and
394
pregnancy induced hypertension) had a six times odds of an adverse pregnancy
395
outcome compared to women who did not experience any form of complication. This
396
finding is in consistence with an earlier study conducted in Marondera district,
397
Zimbabwe45 and other studies in the region, Tanzania, 46 Nigeria47 and globally
398
China. 48, 49 Pregnancy associated conditions like gestational diabetes or
399
hypertension have well recognised adverse effects on pregnancy outcomes.50
400
Placental insufficiency in hypertension during pregnancy, cord prolapse,
401
malpresentation, could explain the high risk of adverse pregnancy outcome among
402
women who experienced complications. Also, intra-uterine bleeding due to
403
antepartum haemorrhage are some of the causes of anaemia in pregnancy that
404
result in neonatal death due to oxygen deficiency.51
405
Lastly, low birth-weight (LBW) <2500 grams has been documented as a risk of
406
adverse pregnancy outcome. Our study showed that neonates with a weight <
407
2500grams were almost twice at risk of adverse outcomes (OR=2.48 p=0.053)
408
though marginally significant. This finding has been established in previous
409
studies.47Neonates born with low birth weight are at increased risk of neonatal
410
deaths due to hypoglycaemia, hypocalcaemia and hypothermia. Successful
411
interventions to care for low birth weight and preterm babies include special baby
412
care unit (SBCU), exclusive breastfeeding and skin-to-skin care “kangaroo mother
413
care.” which is part of the care for these neonates at Sakubva hospital. Sakubva
414
hospital has been practising kangaroo mother care since 2012 and therefore this
415
needs to be intensified.44
416
The current study did not show any association between socio-demographic
417
factors: residential area (rural or urban), marital status and adverse pregnancy
418
outcomes. Though residential areas of low-socio-economic52 status have been
419
shown to influence delivery outcome, the current study did not gather information on
420
economic status of the women.
421
The study suffered from the limitation of being facility based. Hospital based
422
studies may underestimate the true perinatal mortality. A community study is
423
recommended. The study being cross- sectional by design did not capture the
424
events for the nine months duration of pregnancy. Another limitation was, as a
43
425
retrospective analysis, the study was limited to the available data in the delivery
426
register which excluded such factors as paternal education and paternal age when
427
married. Information of outcomes was also limited to the duration the neonate was at
428
the facility and referrals out before seven days could not be followed up to ascertain
429
if perinatal death occurred. A lot of the data was missing which is an indication of
430
poor record keeping at the facility.
431
Though malaria is endemic in the province (Manicaland) the study had a low
432
sample size of 64 for this variable and therefore no meaningful conclusion could be
433
established on the variable. The record of malaria were limited to the delivery time,
434
therefore there is need for further studies to investigate specific variables like malaria
435
and syphilis.
436
Calling of patients, health worker interview to fill in missing data might have
437
subjected the study to recall bias. Our findings in Mutare cannot be generalised to
438
the rest of the population due to selection bias, however can be generalised to
439
similar hospitals within the province. Notwithstanding these limitations, the study
440
identifies important factors associated with adverse pregnancy outcomes in this low
441
resource setting.
442
Conclusion
443
In conclusion, early identification of complications of pregnancy during antenatal
444
care visits is critical toward the reduction of adverse pregnancy outcomes. Breech
445
presentation identification by midwives during the third trimester of pregnancy should
446
be recognised as high risk and therefore must be closely monitored or referred for
447
further management. Prioritization of admission to waiting mother’s shelter of women
448
identified to have complications and those with breech presentation of neonate
449
should be considered in the district. Furthermore high risk pregnancies should be
450
referred to the obstetrician at the earliest time possible for further assistance. It is
451
also recommended that partners support gynaecologists so that they can be
452
available and improve management of complicated cases.
453
Further research on delivery method is recommended to understand the root causes
454
of its association with adverse pregnancy outcomes.
455
456
457
44
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
Abbreviations
ZDHS, Zimbabwe’s 2010/11 Demographic Health Survey; NMR, Neonatal Mortality Ration; MDG, Millennium
Development Goal; HIV/AIDS, Human Immunodeficiency Virus/ Acquired Immunodeficiency Syndrome.
Competing interests
The authors declare that there are no competing interests.
Author’s contributions
BVC conceived and designed the study. BVC, SASO, SN analysed the data. BVC wrote the paper. All authors
read and approved the final manuscript
Author’s information
1. University of Pretoria, Faculty of Health Science, School of Health Systems and Public Health, HW, Synman
Building (North), 31 Bophelo Road, Gezina, Pretoria 2. Medical Research Council of South Africa, Biostatistics
Unit 3. Ministry of Health and Child Care, Manicaland Provincial Medical Directorate, 24C Avenue, Box 323,
Mutare, Zimbabwe.
Acknowledgements
We are thankful to Professors Kuku Voyi and Cheryl McCrindle for technical support in preparation of article for
submission. We are grateful to the Mutare District Medical Officer and team and Manicaland Provincial Medical
Directorate for permitting full access to patient records in the district.
479
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481
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483
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501
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50
673
Appendices
674
Appendix 1: Data capturing sheet
675
Appendix 2: University of Pretoria Ethical Approval
676
Appendix 3: Medical Research Council of Zimbabwe Ethical Approval
677
Appendix 4: Manicaland Provincial Medical Directorate Letter of no Objection
678
to Conduct Research
679
Appendix 5: Mutare District Permission letter to access records
680
Appendix 6: PMC Pregnancy and Childbirth Manuscript Guidelines
681
51
12163733- Chaibva B. V.
Data capture sheet No._______
Determinants of adverse pregnancy outcomes in Mutare health facilities,
Manicaland Province, Zimbabwe.
Section A – Socio- economic factors
Q1. Women residential area
1
Rural
0
Urban
Q2. Social/ marital status of women
1
Currently married
0
Not married (divorced/ Separated / Widowed/ Single)
Q3. Maternal religion
0 Non Apostolic
1 Apostolic
Q4. What is the maternal education level –years of education
1 None (0-≤1)
2 Primary (1- 7 years)
3 Secondary (7-12)
4 Tertiary (≥ 13)
Q5. What is the maternal occupation
1 Formal
0
Informal
Q6. Paternal years of education – years of education
Q7. Paternal age when married
___________________________________________________________________
Section B-Proximal determinants
B1. Maternal factors
Q8. Maternal age at delivery
12163733- Chaibva B. V.
________________________________________________________________
Q9. Obstetric history
0 Nil
1 Adverse obstetric history
Q10. HIV status
0 Negative
1 Positive
Q11. Malaria during pregnancy
1 Positive
0
Negative
Q12. Syphllis test results during pregnancy
1 Positive
0 Negative
B2. Section Child related
Q13. Sex of neonate
1 Female
0
Male
Q14. Birth weight of neonate
0 2500-4000g
1 <2500g
2 >4000g
Q15. What was the gestation age of the infant
1 < 32 weeks
0 ≥32 weeks
Q16. Inter-pregnancy interval
1 ≤2years
12163733- Chaibva B. V.
0
>2years
Q17. Parity
0 1, 2nd and 3rd parity
1 Nulliparous
2 ≥4 parity
Q18. Gravidity
1
<4
0
≥4
B4-Delivery factors
Q21. Birth attendance during delivery
1 Skilled health professional-midwife, obstetrician, doctor
0 Unskilled
Q22. Complications during delivery
0
None
1 Present
Q23. Mode of delivery
0 NVD
1 Non-NVD
Q25. Type of health facility
1 Secondary health institution
0 Tertiary institution
B5-Post natal services
Q26. Post natal services received by neonate
0 No
1 Yes
The Research Ethics Committee, Faculty Health
Sciences, University of Pretoria complies with ICHGCP guidelines and has US Federal wide Assurance.
• FWA 00002567, Approved dd 22 May 2002 and
Expires 20 Oct 2016.
• IRB 0000 2235 IORG0001762 Approved dd
22/04/2014 and Expires 22/04/2017.
UNIVERSITEIT VAN PRETORIA
UNIVERSITY OF PRETORIA
YUN I BESITHI VA PRETORIA
Faculty of Health Sciences Research Ethics Committee
4/09/2014
Approval Certificate
New Application
Ethics Reference No.: 29612014
Title: Determinants of adverse pregnant outcomes in Mutare District Clinics, Manicaland Province , Zimbabwe
Dear Ms Blessmore V. Chaibva
The New Application as supported by documents specified in your cover letter for your research received on the
17107/2014, was approved by the Faculty of Health Sciences Research Ethics Committee on the 2710812014.
Please note the following about your ethics approval :
•
Ethics Approval is valid for 1 year
•
Please remember to use your protocol number (29612014) on any documents or correspondence with the Research Ethics
Committee regarding your research.
•
Please note that the Research Ethics Committee may ask further questions, seek additional information, require further
modification , or monitor the conduct of your research .
Ethics approval is subject to the following:
•
The ethics approval is conditional on the receipt of 6 monthly written Progress Reports , and
•
The ethics approval is conditional on the research being conducted as stipulated by the details of all documents submitted to
the Committee. In the event that a further need arises to change who the investigators are , the methods or any other aspect,
such changes must be submitted as an Amendment for approval by the Committee.
We wish you the best with your research .
Yours sincerely
r
~K"&si'fiiTfers;
MBChB; MMed (lnt) ; MPharMed .
Deputy Chairperson of the Faculty of Health Sciences Research Ethics Committee , University of Pretoria
The Faculty of Health Sciences Research Ethics Committee complies with the SA National Act 61 of 2003 as it pertains to health
research and the United States Code of Federal Regulations Title 45 and 46. This committee abides by the ethical norms and
principles for research, established by the Declaration of Helsinki, the South African Medical Research Council Guidelines as well
as the Guidelines for Ethical Research: Principles Structures and Processes 2004 (Department of Health).
~
0866516047
sD [email protected]
'1! http://www.healthethics-up.co.za
Private Bag X323 , Arcadia , 0007 - 31 Bophelo Road, HW Snyman South Building , Level 2, Room 2.33, Gezina, Pretoria
il' 012 354 1677
C8J
Telephone: 791792/791193
Telefax: (263) - 4 - 790715
E-mail: [email protected]
Website : http://www.mrcz.org.zw
m
Medical Research Council of Zimbabwe
Josiah Tongogara I Mazoe Street
P. 0. Box CY 573
Causeway
Harare
APPROVAL
REF: MRCZ/B/709
24 September 2014
Blessmore Chaibva
University of Pretoria
South Africa
RE: Determinants Of Adverse Pregnancy Outcomes In Mutare District, Manicaland Province
Thank you for the application for review of Research Activity that you submitted to the Medical Research
Council of Zimbabwe (MRCZ). Please be advised that the Medical Resear.ch Council of Zimbabwe has
reviewed and approved your application to conduct the above titled study.
This approval is based on the review and approval of the following documents that were submitted to MRCZ
for review:a) Study proposal
b) Data Collection Tools
•
•
•
TYPE OF MEETING
EFFECTIVE AI>PROVAL DATE
EXPIRATION DATE
:Expedited
: 24 September 2014
: 23 September 2015
After this date, this project may only continue upon renewal. For purposes of renewal, a progress report on
a standard form obtainable from the MRCZ Offices should be submitted three months before the expiration
date for continuing review.
• SERIOUS ADVERSE EVENT REPORTING: All serious problems having to do with subject safety must
be reported to the Institutional Ethical Review Committee (IERC) as well as the MRCZ within 3 working days
using standard forms obtainable from the MRCZ Offices or website.
• MODIFICATIONS: Prior MRCZ and IERC approval using standard forms obtainable from the MRCZ
Offices is required before implementing any changes in the Protocol (including changes in the consent
documents).
• TERMINATION OF STUDY: On termination of a study, a report has to be submitted to the MRCZ using
standard forms obtainable [rom the MRCZ Offices or website.
• QUESTIONS: Please contact the MRCZ on Telephone No. (04) 791792, 791193 or by e-mail on
[email protected]
•
•
Other
Please be reminded to send in copies of your research results for our records as well as for Health
Research Database.
You're also encouraged to submit electronic copies of your publications in peer-reviewed journals that
may emanate from this study.
MEDICAL RESEARCH COUNeiL OF ZIM!A~W!
Yours Faithfully
~ ..
n
....
.................................
1
2014 -11- 4
MRCZ SECRETARIAT
FORCHAIRPERSON
MEDICAL RESEARCH COUNCIL OF ZIMBABWE p o. BOX CY 573 CAUSEWAY, HARARE
I
APPROVED
PROMOTING TilE ETHICAL CONDUCT OF HEALTH RESEARCH
Reference:
Telephone: 60624/60655
Fax:60698/64401
ZIMBABWE
PROVINCIAL MEDICAL DIRECTOR
MANICALAND
P.O. Box 323
Mutare
University of Pretoria
Faculty of Health Sciences
Research Ethics Committee
School of Health Systems & Public Health
HW, Synman Building (North)
31 Bophelo Road
Gezina
Pretoria
Dear Sir/Madam
REF: DECLARATION OF NO OBJECTION TO CONDUCT RESEARCH-Ms B V CHAIBVA
This serves to inform that the Manica land Provincial Medical Director has granted Ms. B V
Chaibva permission to conduct her research titled: "Determinants of adverse pregnancy
outcomes in Mutare district, Manicaland Province, Zimbabwe."
We therefore declare that we have no objection to her accessing patient records to
facilitate her research provided that approval of her protocol is granted first by the
University of Pretoria, Research Ethics Committee and secondly by Medical Research
Council of Zimbabwe.
Yours sincerely
PR<:MNCIAL MEDICAL o:;·£-,..;:)R'
MANICAI ~NO
2014
,., . , un ,_,/
-~.;
Dr P T Mafaune
Manicaland Provincial Medical Director
Permission to access Records I Files I Data base at Health
Facilities in Mutare Urban
To:
Provincial Medical Director
Manicaland Province
From: The Investigator
Mutare Facilities
B V Chaibva _ __
Dr Mafaune
Re:
Permission to do research at Health Facilities in Mutare Health Facili ties
I am a Master of Public Health student with the University of Pretoria. I am requesting permission to
conduct a study on the Determinants of adverse pregnancy outcomes in Mutare Health facilities that
involves access to patient records .
The request is lodged with you in terms of the requirements of the Promotion of Access to Information Act.
No. 2 of 2000.
The title of the study is: Determinants of adverse pregnancy outcomes in Mutare health
facilities
The researcher requests access to the following information:
Access to the clinical files, record book and the data base.
I intend to publish the findings of the study in a professional journal and/ or at professional meeting like
symposia, congresses, or other meetings of such a nature.
I intend to protect the personal identity of the patients by assigning each patient a random code number.
I undertake not to proceed with the study until I have received approval from the Faculty of Health Sciences
Research Ethics Committee, University of Pretoria, and the Medical and Research Council of Zimbabwe.
Yours sincerely
Permission to do the research study at Mutare Health Facilities
and to access the information as requested, is hereby approved .
Provincial Medical Director
Manicaland Province
Dr rv\AFAL.t,_}6
-·
.
.
-
PRO 1f\JC:A.L MEDICAL DlRECiOR
f'v iANICAl i.:..1,JD
2014 -05- 2 7
tf
PO BOX 323, !VIUTARE
ZIMI3ASVVI:: TE L. 020-60624
,
,-,
f
Permission to access Records I Files I Data base at Mutare Health Facilities
To:
The District Medical Officer
Mutare District
Zimbabwe
From: Blessmore V Chaibva
University of Pretoria
Facuity of Health Science
School of Health Systems and Public Health
HW, Synman Building (North), 31 Bophelo Road, Gezina,
Pretoria
South Africa
Dear Sir
Re:
Permission to do research at Mutare Health facilities
THE TITLE OF THE STUDY IS: DETERMINANTS OF ADVERSE PREGNANCY OUTCOMES AT
MUTARE HEALTH FACILITIES, MANICALAND PROVINCE, ZIMBABWE
The request is lodged with you in terms of the requirements of the Promotion of Access to Information Act.
No.2 of 2000.
I am a student with the University of Pretoria, pursuing my Master of Public Health Degree (MPH)
Epidemiology and Biostatistics- Monitoring and Evaluation sub-track programme. I am working with Prof
Andy Beke, my academic supervisor from the University of Pretoria, School of Health System and Public
Health. I hereby make a request on behalf of all of us to conduct the above mention research at Facilities in
Mutare facilities.
The research is a retrospective cross-sectional analytical study that involves access to patient clinical files,
record book and databases with records from January 2014 to June 2014 on all pregnant women who were
attended at health facilities.
We intend to publish the findings of the study in a professional journal and/ or at professional meeting like
symposia, congresses, or other meetings of such a nature.
We intend to protect the personal identity of the patients by assigning each patient a random code number.
We undertake not to proceed with the study until we have received approval from the Faculty of Health
Sciences Research Ethics Committee, University of Pretoria.
Yours sincerely
Permission to do the research at Mutare Health Facilities and to
access the information as requested, is hereby approved.
Name and title of Medical Officer:
DR.
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of data, or analysis and interpretation of data; 2) have been involved in drafting the
manuscript or revising it critically for important intellectual content; 3) have given final
approval of the version to be published; and 4) agree to be accountable for all aspects of the
work in ensuring that questions related to the accuracy or integrity of any part of the work
are appropriately investigated and resolved. Each author should have participated
sufficiently in the work to take public responsibility for appropriate portions of the content.
Acquisition of funding, collection of data, or general supervision of the research group,
alone, does not justify authorship.
We suggest the following kind of format (please use initials to refer to each author's
contribution): AB carried out the molecular genetic studies, participated in the sequence
alignment and drafted the manuscript. JY carried out the immunoassays. MT participated in
the sequence alignment. ES participated in the design of the study and performed the
statistical analysis. FG conceived of the study, and participated in its design and
coordination and helped to draft the manuscript. All authors read and approved the final
manuscript.
All contributors who do not meet the criteria for authorship should be listed in an
acknowledgements section. Examples of those who might be acknowledged include a
person who provided purely technical help, writing assistance, or a department chair who
provided only general support.
Authors' information
You may choose to use this section to include any relevant information about the author(s)
that may aid the reader's interpretation of the article, and understand the standpoint of the
author(s). This may include details about the authors' qualifications, current positions they
hold at institutions or societies, or any other relevant background information. Please refer
to authors using their initials. Note this section should not be used to describe any
competing interests.
Acknowledgements
Please acknowledge anyone who contributed towards the article by making substantial
contributions to conception, design, acquisition of data, or analysis and interpretation of
data, or who was involved in drafting the manuscript or revising it critically for important
intellectual content, but who does not meet the criteria for authorship. Please also include
the source(s) of funding for each author, and for the manuscript preparation. Authors must
describe the role of the funding body, if any, in design, in the collection, analysis, and
interpretation of data; in the writing of the manuscript; and in the decision to submit the
manuscript for publication. Please also acknowledge anyone who contributed materials
essential for the study. If a language editor has made significant revision of the manuscript,
we recommend that you acknowledge the editor by name, where possible.
The role of a scientific (medical) writer must be included in the acknowledgements section,
including their source(s) of funding. We suggest wording such as 'We thank Jane Doe who
provided medical writing services on behalf of XYZ Pharmaceuticals Ltd.'
Authors should obtain permission to acknowledge from all those mentioned in the
Acknowledgements section.
Endnotes
Endnotes should be designated within the text using a superscript lowercase letter and all
notes (along with their corresponding letter) should be included in the Endnotes section.
Please format this section in a paragraph rather than a list.
References
All references, including URLs, must be numbered consecutively, in square brackets, in the
order in which they are cited in the text, followed by any in tables or legends. Each
reference must have an individual reference number. Please avoid excessive referencing. If
automatic numbering systems are used, the reference numbers must be finalized and the
bibliography must be fully formatted before submission.
Only articles, datasets, clinical trial registration records and abstracts that have been
published or are in press, or are available through public e-print/preprint servers, may be
cited; unpublished abstracts, unpublished data and personal communications should not be
included in the reference list, but may be included in the text and referred to as
"unpublished observations" or "personal communications" giving the names of the involved
researchers. Obtaining permission to quote personal communications and unpublished data
from the cited colleagues is the responsibility of the author. Footnotes are not allowed, but
endnotes are permitted. Journal abbreviations follow Index Medicus/MEDLINE. Citations in
the reference list should include all named authors, up to the first 30 before adding 'et al.'..
Any in press articles cited within the references and necessary for the reviewers' assessment
of the manuscript should be made available if requested by the editorial office.
Style files are available for use with popular bibliographic management software:
•
•
•
•
BibTeX
EndNote style file
Reference Manager
Zotero
Examples of the BMC Pregnancy and Childbirth reference style are shown below. Please
ensure that the reference style is followed precisely; if the references are not in the correct
style they may have to be retyped and carefully proofread.
All web links and URLs, including links to the authors' own websites, should be given a
reference number and included in the reference list rather than within the text of the
manuscript. They should be provided in full, including both the title of the site and the URL,
in the following format: The Mouse Tumor Biology
Database [http://tumor.informatics.jax.org/mtbwi/index.do]. If an author or group of
authors can clearly be associated with a web link, such as for weblogs, then they should be
included in the reference.
Examples of the BMC Pregnancy and Childbirth reference style
Article within a journal
Koonin EV, Altschul SF, Bork P: BRCA1 protein products: functional motifs. Nat
Genet 1996,13:266-267.
Article within a journal supplement
Orengo CA, Bray JE, Hubbard T, LoConte L, Sillitoe I: Analysis and assessment of ab initio
three-dimensional prediction, secondary structure, and contacts
prediction. Proteins 1999,43(Suppl 3):149-170.
In press article
Kharitonov SA, Barnes PJ: Clinical aspects of exhaled nitric oxide. Eur Respir J, in press.
Published abstract
Zvaifler NJ, Burger JA, Marinova-Mutafchieva L, Taylor P, Maini RN: Mesenchymal cells,
stromal derived factor-1 and rheumatoid arthritis [abstract]. Arthritis
Rheum 1999, 42:s250.
Article within conference proceedings
Jones X: Zeolites and synthetic mechanisms. In Proceedings of the First National Conference
on Porous Sieves: 27-30 June 1996; Baltimore. Edited by Smith Y. Stoneham: ButterworthHeinemann; 1996:16-27.
Book chapter, or article within a book
Schnepf E: From prey via endosymbiont to plastids: comparative studies in
dinoflagellates. In Origins of Plastids. Volume 2. 2nd edition. Edited by Lewin RA. New York:
Chapman and Hall; 1993:53-76.
Whole issue of journal
Ponder B, Johnston S, Chodosh L (Eds): Innovative oncology. In Breast Cancer
Res 1998, 10:1-72.
Whole conference proceedings
Smith Y (Ed): Proceedings of the First National Conference on Porous Sieves: 27-30 June
1996; Baltimore. Stoneham: Butterworth-Heinemann; 1996.
Complete book
Margulis L: Origin of Eukaryotic Cells. New Haven: Yale University Press; 1970.
Monograph or book in a series
Hunninghake GW, Gadek JE: The alveolar macrophage. In Cultured Human Cells and
Tissues.Edited by Harris TJR. New York: Academic Press; 1995:54-56. [Stoner G (Series
Editor): Methods and Perspectives in Cell Biology, vol 1.]
Book with institutional author
Advisory Committee on Genetic Modification: Annual Report. London; 1999.
PhD thesis
Kohavi R: Wrappers for performance enhancement and oblivious decision graphs. PhD
thesis. Stanford University, Computer Science Department; 1995.
Link / URL
The Mouse Tumor Biology Database [http://tumor.informatics.jax.org/mtbwi/index.do]
Link / URL with author(s)
Corpas M: The Crowdfunding Genome Project: a personal genomics community with open
source values [http://blogs.biomedcentral.com/bmcblog/2012/07/16/the-crowdfundinggenome-project-a-personal-genomics-community-with-open-source-values/]
Dataset with persistent identifier
Zheng, L-Y; Guo, X-S; He, B; Sun, L-J; Peng, Y; Dong, S-S; Liu, T-F; Jiang, S; Ramachandran, S;
Liu, C-M; Jing, H-C (2011): Genome data from sweet and grain sorghum (Sorghum
bicolor).GigaScience Database. http://dx.doi.org/10.5524/100012.
Clinical trial registration record with persistent identifier
Mendelow, AD (2006): Surgical Trial in Lobar Intracerebral Haemorrhage. Current
Controlled Trials. http://dx.doi.org/10.1186/ISRCTN22153967
Preparing illustrations and figures
Illustrations should be provided as separate files, not embedded in the text file. Each figure
should include a single illustration and should fit on a single page in portrait format. If a
figure consists of separate parts, it is important that a single composite illustration file be
submitted which contains all parts of the figure. There is no charge for the use of color
figures.
Please read our figure preparation guidelines for detailed instructions on maximising the
quality of your figures.
Formats
The following file formats can be accepted:
PDF (preferred format for diagrams)
• DOCX/DOC (single page only)
• PPTX/PPT (single slide only)
• EPS
• PNG (preferred format for photos or images)
• TIFF
• JPEG
• BMP
Figure legends
•
The legends should be included in the main manuscript text file at the end of the document,
rather than being a part of the figure file. For each figure, the following information should
be provided: Figure number (in sequence, using Arabic numerals - i.e. Figure 1, 2, 3 etc);
short title of figure (maximum 15 words); detailed legend, up to 300 words.
Please note that it is the responsibility of the author(s) to obtain permission from the
copyright holder to reproduce figures or tables that have previously been published
elsewhere.
Preparing tables
Each table should be numbered and cited in sequence using Arabic numerals (i.e. Table 1, 2,
3 etc.). Tables should also have a title (above the table) that summarizes the whole table; it
should be no longer than 15 words. Detailed legends may then follow, but they should be
concise. Tables should always be cited in text in consecutive numerical order.
Smaller tables considered to be integral to the manuscript can be pasted into the end of the
document text file, in A4 portrait or landscape format. These will be typeset and displayed
in the final published form of the article. Such tables should be formatted using the 'Table
object' in a word processing program to ensure that columns of data are kept aligned when
the file is sent electronically for review; this will not always be the case if columns are
generated by simply using tabs to separate text. Columns and rows of data should be made
visibly distinct by ensuring that the borders of each cell display as black lines. Commas
should not be used to indicate numerical values. Color and shading may not be used; parts
of the table can be highlighted using symbols or bold text, the meaning of which should be
explained in a table legend. Tables should not be embedded as figures or spreadsheet files.
Larger datasets or tables too wide for a portrait page can be uploaded separately as
additional files. Additional files will not be displayed in the final, laid-out PDF of the article,
but a link will be provided to the files as supplied by the author.
Tabular data provided as additional files can be uploaded as an Excel spreadsheet (.xls ) or
comma separated values (.csv). As with all files, please use the standard file extensions.
Preparing additional files
Although BMC Pregnancy and Childbirth does not restrict the length and quantity of data
included in an article, we encourage authors to provide datasets, tables, movies, or other
information as additional files.
Please note: All Additional files will be published along with the article. Do not include files
such as patient consent forms, certificates of language editing, or revised versions of the
main manuscript document with tracked changes. Such files should be sent by email
to [email protected], quoting the Manuscript ID number.
Results that would otherwise be indicated as "data not shown" can and should be included
as additional files. Since many weblinks and URLs rapidly become broken, BMC Pregnancy
and Childbirth requires that supporting data are included as additional files, or deposited in
a recognized repository. Please do not link to data on a personal/departmental website. The
maximum file size for additional files is 20 MB each, and files will be virus-scanned on
submission.
Additional files can be in any format, and will be downloadable from the final published
article as supplied by the author. We recommend CSV rather than PDF for tabular data.
Certain supported files formats are recognized and can be displayed to the user in the
browser. These include most movie formats (for users with the Quicktime plugin), miniwebsites prepared according to our guidelines, chemical structure files (MOL, PDB),
geographic data files (KML).
If additional material is provided, please list the following information in a separate section
of the manuscript text:
•
•
•
•
File name (e.g. Additional file 1)
File format including the correct file extension for example .pdf, .xls, .txt, .pptx
(including name and a URL of an appropriate viewer if format is unusual)
Title of data
Description of data
Additional files should be named "Additional file 1" and so on and should be referenced
explicitly by file name within the body of the article, e.g. 'An additional movie file shows this
in more detail [see Additional file 1]'.
Additional file formats
Ideally, file formats for additional files should not be platform-specific, and should be
viewable using free or widely available tools. The following are examples of suitable
formats.
Additional documentation
o PDF (Adode Acrobat)
• Animations
o SWF (Shockwave Flash)
• Movies
o MP4 (MPEG 4)
o MOV (Quicktime)
• Tabular data
o XLS, XLSX (Excel Spreadsheet)
o CSV (Comma separated values)
•
As with figure files, files should be given the standard file extensions.
Mini-websites
Small self-contained websites can be submitted as additional files, in such a way that they
will be browsable from within the full text HTML version of the article. In order to do this,
please follow these instructions:
1. Create a folder containing a starting file called index.html (or index.htm) in the root.
2. Put all files necessary for viewing the mini-website within the folder, or sub-folders.
3. Ensure that all links are relative (ie "images/picture.jpg" rather than
"/images/picture.jpg" or "http://yourdomain.net/images/picture.jpg" or
"C:\Documents and Settings\username\My Documents\miniwebsite\images\picture.jpg") and no link is longer than 255 characters.
4. Access the index.html file and browse around the mini-website, to ensure that the
most commonly used browsers (Internet Explorer and Firefox) are able to view all
parts of the mini-website without problems, it is ideal to check this on a different
machine.
5. Compress the folder into a ZIP, check the file size is under 20 MB, ensure that
index.html is in the root of the ZIP, and that the file has .zip extension, then submit
as an additional file with your article.
Style and language
General
Currently, BMC Pregnancy and Childbirth can only accept manuscripts written in English.
Spelling should be US English or British English, but not a mixture.
There is no explicit limit on the length of articles submitted, but authors are encouraged to
be concise.
BMC Pregnancy and Childbirth will not edit submitted manuscripts for style or language;
reviewers may advise rejection of a manuscript if it is compromised by grammatical errors.
Authors are advised to write clearly and simply, and to have their article checked by
colleagues before submission. In-house copyediting will be minimal. Non-native speakers of
English may choose to make use of a copyediting service.
Language editing
For authors who wish to have the language in their manuscript edited by a native-English
speaker with scientific expertise, BioMed Central recommends Edanz. BioMed Central has
arranged a 10% discount to the fee charged to BioMed Central authors by Edanz. Use of an
editing service is neither a requirement nor a guarantee of acceptance for publication.
Please contact Edanz directly to make arrangements for editing, and for pricing and
payment details.
Help and advice on scientific writing
The abstract is one of the most important parts of a manuscript. For guidance, please visit
our page on Writing titles and abstracts for scientific articles.
Tim Albert has produced for BioMed Central a list of tips for writing a scientific
manuscript. American Scientist also provides a list of resources for science writing. For more
detailed guidance on preparing a manuscript and writing in English, please visit the BioMed
Central author academy.
Abbreviations
Abbreviations should be used as sparingly as possible. They should be defined when first
used and a list of abbreviations can be provided following the main manuscript text.
Typography
• Please use double line spacing.
• Type the text unjustified, without hyphenating words at line breaks.
• Use hard returns only to end headings and paragraphs, not to rearrange lines.
• Capitalize only the first word, and proper nouns, in the title.
• All lines and pages should be numbered. Authors are asked to ensure that line
numbering is included in the main text file of their manuscript at the time of
submission to facilitate peer-review. Once a manuscript has been accepted, line
numbering should be removed from the manuscript before publication. For authors
submitting their manuscript in Microsoft Word please do not insert page breaks in your
manuscript to ensure page numbering is consistent between your text file and the PDF
generated from your submission and used in the review process.
• Use the BMC Pregnancy and Childbirth reference format.
• Footnotes are not allowed, but endnotes are permitted.
• Please do not format the text in multiple columns.
• Greek and other special characters may be included. If you are unable to reproduce a
particular special character, please type out the name of the symbol in full. Please
ensure that all special characters used are embedded in the text, otherwise they will
be lost during conversion to PDF.
Units
SI units should be used throughout (liter and molar are permitted, however).
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