Abstract

Background:Robust data summarizing the prevalence of pregnancy and neonatal outcomes in low- and middle-income countries are critically important for studies evaluating investigational products for HIV prevention and treatment in pregnant and breastfeeding women. In preparation for studies evaluating the safety of the dapivirine vaginal ring for HIV prevention in pregnancy, we conducted a systematic literature review and meta-analyses to summarize the prevalence of pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe.Methods:Ten individual systematic literature reviews were conducted to identify manuscripts presenting prevalence data for 12 pregnancy and neonatal outcomes [pregnancy loss, stillbirth, preterm birth, low birthweight (LBW), neonatal mortality, congenital anomaly, chorioamnionitis, postpartum endometritis, postpartum hemorrhage, gestational hypertension, preeclampsia/eclampsia, and preterm premature rupture of membranes (PPROM)]. Studies included in the meta-analyses were published between January 1, 1998, and July 11, 2018, provided numerator and denominator data to support prevalence estimation, and included women of any HIV serostatus. Random-effects meta-analyses were conducted to estimate the pooled prevalence and 95% confidence interval (CI) for each outcome overall, by country, and by HIV status.Results:A total of 152 manuscripts were included across the 12 outcomes. Overall, the frequency of stillbirth (n = 75 estimates), LBW (n = 68), and preterm birth (n = 67) were the most often reported. However, fewer than 10 total manuscripts reported prevalence estimates for chorioamnionitis, endometritis, or PPROM. The outcomes with the highest pooled prevalence were preterm birth (12.7%, 95%CI 11.2–14.3), LBW (11.7%, 95%CI 10.6–12.9), and gestational hypertension (11.4%, 95%CI 7.8–15.7). Among the outcomes with the lowest pooled prevalence estimates were neonatal mortality (1.7%, 95%CI 1.4–2.1), pregnancy loss [1.9%, 95%CI 1.1–2.8, predominately studies (23/29) assessing losses occurring after the first trimester], PPROM (2.2%, 95%CI 1.5–3.2), and stillbirth (2.5%, 95%CI 2.2–2.7).Conclusions:Although this review identified numerous prevalence estimates for some outcomes, data were lacking for other important pregnancy-related conditions. Additional research in pregnant populations is needed for a thorough evaluation of investigational products, including for HIV prevention and treatment, and to inform better estimates of the burden of adverse pregnancy outcomes globally.

Highlights

  • In Sub-Saharan Africa, cisgender women of reproductive age represent the largest proportion of those with new HIV infections, making them a key focus for HIV testing, treatment, and prevention efforts [1]

  • As all enrolled women will be using an HIV prevention product during pregnancy, the frequency of pregnancy complications, pregnancy outcomes, and neonatal outcomes will be compared with the rates in the general population in Malawi, South Africa, Uganda, and Zimbabwe, where the DELIVER study is being conducted

  • Several additional outcomespecific sensitivity and subgroup analyses were conducted, which included restricting to studies of low birthweight (LBW) and preterm birth when these outcomes were ascertained for live-births only, assessing antepartum vs. intrapartum stillbirth prevalence estimates, restricting to studies reporting congenital anomalies from randomized trials with rigorous assessment for anomalies, and restricting to studies reporting postpartum hemorrhage (PPH) defined as ≥500 ml of blood loss

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Summary

Introduction

In Sub-Saharan Africa, cisgender women of reproductive age represent the largest proportion of those with new HIV infections, making them a key focus for HIV testing, treatment, and prevention efforts [1]. Despite the potential increased susceptibility of HIV faced by women during these clinically complex periods of their lives, pregnant and postpartum women are frequently excluded from clinical trials evaluating investigational products for HIV treatment or prevention. There is a scientific and ethical imperative to responsibly include pregnant women in research evaluating the safety and efficacy of investigational products In line with this imperative, the Microbicide Trials Network (MTN) is conducting the DELIVER study, a phase 3b, randomized, open-label safety trial of the dapivirine vaginal ring (25 mg), and oral preexposure prophylaxis (PrEP) (Truvada: 200 mg emtricitabine [FTC]/300 mg tenofovir disoproxil fumarate [TDF]) for HIV prevention in pregnant cisgender women (MTN-042; ClinicalTrials.gov Number: NCT03965923). In preparation for studies evaluating the safety of the dapivirine vaginal ring for HIV prevention in pregnancy, we conducted a systematic literature review and meta-analyses to summarize the prevalence of pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe

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