Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial

BMC Pregnancy and Childbirth
Joan T PriceJeffrey S A Stringer

Abstract

Each 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. The 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 ...Continue Reading

Associated Clinical Trials

References

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Sep 25, 2019·Gates Open Research·Marcela C CastilloBellington Vwalika

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Citations

Feb 5, 2021·Gates Open Research·A Brianne BotaKumanan Wilson
Feb 16, 2021·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Joan T PriceJeffrey S A Stringer

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Methods Mentioned

BETA
pregnancy

Clinical Trials Mentioned

NCT03297216

Software Mentioned

Makena®

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