NCT03297216

Improving Pregnancy Outcomes With Progesterone

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.

Detailed description

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.

Conditions

• Pre-term Birth
• HIV-1-infection

Interventions

Type	Name	Description
DRUG	17P	Synthetic progestin
OTHER	Placebo	Non-active placebo comparator

Timeline

• Start date: 2018-02-07
• Primary completion: 2020-06-25
• Completion: 2020-08-06
• First posted: 2017-09-29
• Last updated: 2021-07-22
• Results posted: 2021-07-09

Locations

2 sites across 1 country: Zambia

Regulatory

• FDA-regulated drug study