Sexually Transmitted Infection (STI) in Pregnancy and Adverse Birth Outcomes; A Case-control Study
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Date
2023-01-19
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Kamuzu University of Health Sciences
Abstract
Type of Research Study:
A cross-sectional survey and nested case-control study.
The problem: Sexually transmitted infections (STIs) are associated with increased rates of
preterm birth, stillbirth and low birth weight (LBW). In Malawi STIs are diagnosed by syndromic
ascertainment which has poor sensitivity in antenatal mothers. The prevalence of these
diseases in the antenatal period and their contribution to adverse birth outcomes are not
known in Malawi. This is critical as they are highly modifiable.
This study will be done as part of the DIPLOMATIC collaboration. Through the COMREC
approved TUDA study (P06/19/2714), the DIPLOMATIC collaboration has established midwife
capacity in antenatal ultrasound for the determination of gestational age at Queen Elizabeth
Central Hospital (QECH). This platform will be utilised in the current study to accurately
ascertain the outcomes of prematurity and low birth weight. The DIPLOMATIC group is
committed to the implementation of evidence-based practices with the aim of reducing preterm
birth, stillbirth and neonatal mortality in Malawi and Zambia.
Aim: To determine the contribution of sexually transmitted infections (STI) in the antenatal
period to adverse birth outcomes at QECH
Primary objectives:
1. To determine the prevalence of STIs (N. gonorrhea, C. trachomatis, M. genitalium, T.
vaginalis, T. pallidum, Herpes Simplex Virus and HIV in women who attend QECH for
delivery of their infants.
2. To determine the attributable fraction of adverse birth outcomes at QECH with a
confirmed diagnosis of at least one STI in the peripartum period.
Secondary objectives:
1. To generate pilot data on the clinical outcomes of mother-infant pairs co-infected with
HIV and any other STI
2. To evaluate the accuracy of the syndromic approach to the diagnosis of STIs in
pregnancy compared to gold standard laboratory diagnostics.
3. To determine the coverage of antenatal diagnosis, treatment and partner notification
and treatment of STIs.
4. To determine the role of rapid point of care tests (POCT) for the differentiation of
early versus latent gestational syphilis and the diagnosis and management of
congenital syphilis.
5. To generate pilot data on the role of vaginal microbial composition in preterm birth
and mother to child transmission of HIV.
Methodology: A cross-sectional survey and nested case-control study of pregnant women,
recruited at delivery will be done at Queen Elizabeth Central Hospital, Blantyre, Malawi. A
composite case definition for adverse birth outcome will include all stillborn, preterm, low birth
weight (LBW) infants or infants admitted to NICU within 24 hours of birth. Each case will be
matched with a mother of a healthy term infant. Multiplex PCR will be done on vaginal swabs
in cases and controls to screen for all common STIs (N. gonorrhea, C. trachomatis, M.
genitalium, T. vaginalis, T. pallidum, Herpes Simplex Virus) and HIV and syphilis status will
be determined on maternal and infant serum. There is a planned sub-group analysis by HIV
sero-status. We will recruit 650 cases and 650 controls to give 80% power to detect a 50%
difference between groups, α=0.05 and allow prevalence estimates for each STI with +/-5%
margin of error margin of error.
Expected Findings: This study will provide prevalence data for curable STIs among postpartum
women and assess their contribution to adverse birth outcomes. In addition, this study
will provide information on the burden of neonatal disease in newborns exposed to STIs in the
pre- and peri-partum period.
Dissemination: Research findings will be shared with health care workers at QECH and with
participants with the help of the MLW science communication team. Data will be shared with
the Malawi College of Medicine and Malawi College of Medicine Research Ethics Committee,
Malawi Ministry of Health and published in peer reviewed publications. Data collected at
QECH will be presented as standalone findings in conferences and peer-reviewed
publications locally and shared with relevant clinicians and policy makers.
Description
Keywords
STI in pregnancy and birth outcome