Improving Pregnancy Outcomes With Progesterone (IPOP)

University of North Carolina (UNC)

Status and phase: Completed; Phase 3

Conditions: HIV-1-infection; Pre-term Birth

Treatments: Other: Placebo; Drug: 17P

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03297216

1R01HD087119 (U.S. NIH Grant/Contract)

17-1173

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups, including a placebo group

250 mg 17P

Active Comparator group

Description:

weekly intramuscular injection of 250mg 17P

Treatment:

Drug: 17P

Placebo

Placebo Comparator group

Description:

weekly intramuscular injection of indistinguishable placebo

Treatment:

Other: Placebo