HIV-1-infection Clinical Trial
Official title:
Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Individual participants will be followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. ;
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