Improving Pregnancy Outcomes With Progesterone

• Status: Completed
• Trial end date: 2020-08-06
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: AMAG Pharmaceuticals, Inc.; Bill and Melinda Gates Foundation; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate; Progesterone

Criteria

Inclusion Criteria:

• 18 years of age or older

• less than 24 0/7 weeks of gestation

• viable intrauterine singleton pregnancy confirmed by ultrasound

• antibody-confirmed HIV-1 infection

• currently receiving antiretroviral l therapy (ART) or intending to commence ART in pregnancy

• ability and willingness to provide written informed consent

• intent to remain in current geographical area of residence for the duration of study

• willing to adhere to weekly study visit schedule

Exclusion Criteria:

• confirmed prior spontaneous preterm birth

• multiple gestation

• known uterine anomaly

• planned or in situ cervical cerclage

• major fetal anomaly detected on screening ultrasound

• indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)

• threatened abortion, preterm labor, or ruptured membranes at time of enrollment

• known allergy or medical comorbidity listed as a contraindication to 17P in the prescribing information

• prior participation in the trial

• any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.