Sexually Transmitted Infection (STI) in Pregnancy and Adverse Birth Outcomes; A Case-control Study

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Kamuzu University of Health Sciences
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.
STI in pregnancy and birth outcome