MTN-042B

Primary Objectives

• To determine the frequency of pregnancy outcomes (full term and premature live births, as well as stillbirth/intrauterine fetal demise) in sub-Saharan Africa

Study Summary
MTN-042B was a cross-sectional chart review study designed to provide an estimate of pregnancy outcome frequency data (term delivery, preterm delivery, still birth) for MTN-042 and other clinical trials involving pregnant women in sub-Saharan Africa. The medical charts of all women delivering or receiving immediate post-partum care (within one week of delivery) at one or two facilities affiliated with each of the 4 sites within an 8-week period were abstracted; once the participant was discharged home and/or seven days from delivery has passed if the participant remains in the facility, the data entry was considered complete.

Data abstraction was completed in March 2020. The primary manuscript was published in PLoS One on March 31, 2021. A total of two papers have been published from this study.    

Primary Results
Data from 10,138 records were abstracted across all four sites (Blantyre n = 2,384; Johannesburg n = 1,888; Kampala n = 3,708; Chitungwiza and Harare n = 2,158), which included 10,426 pregnancy outcomes. The prevalence of preterm birth was 13% (range across sites: 10.4-20.7) and 4.1% of deliveries resulted in stillbirth (range: 3.1-5.5). The most commonly noted pregnancy complication was gestational hypertension, reported among 4.4% of pregnancies. Among pregnancies resulting in a live birth, 15.5% were low birthweight (range: 13.8-17.4) and 2.0% resulted in neonatal death (range:1.2-3.2). Suspected congenital anomalies were noted in 1.2% of pregnancies. This study provides systematically collected data on background rates of pregnancy outcomes, pregnancy complications and neonatal outcomes that can be used as a reference in support of ongoing HIV prevention studies. In addition, estimates from this study provide important background data for future studies of investigational products evaluated in pregnancy in these urban settings.