Abstract
BackgroundEach year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. Maternal HIV infection increases a woman’s risk of delivering prematurely, and antiretroviral therapy (ART) may compound this risk. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia.MethodsThe Improving Pregnancy Outcomes with Progesterone (IPOP) study is a Phase III double-masked, placebo-controlled, randomized trial of intramuscular 17-alpha hydroxprogesterone caproate (17P) to prevent preterm birth in HIV-infected women. A total of 800 women will be recruited prior to 24 weeks of gestation and randomly allocated to 17P or placebo administered by weekly intramuscular injection. The primary outcome will be a composite of live birth prior to 37 completed gestational weeks or stillbirth at any gestational age. Secondary outcomes will include very preterm birth (< 34 weeks), extreme preterm birth (< 28 weeks), small for gestational age (<10th centile), low birth weight (< 2500 g), and neonatal outcomes. In secondary analysis, we will assess whether specific HIV-related covariates, including the timing of maternal ART initiation relative to conception, is associated with progesterone’s prophylactic efficacy, if any.DiscussionWe hypothesize that weekly prenatal 17P will reduce the risk of HIV-related preterm birth. An inexpensive intervention to prevent preterm birth among pregnant women with HIV could have substantial global public health impact.Trial registrationNCT03297216; September 29, 2017.
Highlights
Each year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries
Neonatal mortality remains elevated in Human immunodeficiency virus (HIV)-infected pregnant women on antiretroviral therapy (ART) compared to HIV-uninfected women; in a study comparing women on efavirenz or dolutegravir-based ART, neonatal mortality was 2.3% among HIV-infected compared to 1.4% among HIV-uninfected women [9]
The global epidemics of preterm birth and HIV converge in sub-Saharan Africa, where the skilled providers and resources needed to care for preterm neonates are scarce
Summary
An estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia. Of 1.5 million women living with HIV who become pregnant each year, the overwhelming majority reside in either sub-Saharan Africa (87%) or South Asia (5%) [4]. While expanding coverage of antiretroviral therapy (ART) among pregnant women living with HIV has drastically reduced the incidence of mother-to-child transmission, maternal ART exposure does not appear to ameliorate the increased risk of PTB in HIV-infected pregnant women [5,6,7,8,9,10]. A considerable proportion of this neonatal mortality appears to be secondary to PTB [6]
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