Improving Pregnancy Outcomes With Progesterone

University of North Carolina, Chapel Hill800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

800

Conditions

Pre-term Birth HIV-1-infection

Interventions

17PDRUG

Synthetic progestin

PlaceboOTHER

Non-active placebo comparator

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Kamwala District Clinic

Lusaka, Zambia

University Teaching Hospital

Lusaka, Zambia

Outcomes

Primary Outcomes

Number of Participants Experiencing Preterm Births or Stillbirths

A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age

Time frame: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths

Secondary Outcomes

Number of Participants Experiencing Preterm Birth <37 Weeks

Delivery prior to 37 gestational weeks

Time frame: At delivery, up to 37 weeks of gestation

Number of Participants Experiencing Preterm Birth <34 Weeks

Delivery prior to 34 gestational weeks

Time frame: At delivery, up to 34 weeks of gestation

Number of Participants Experiencing Preterm Birth <28 Weeks

Delivery prior to 28 gestational weeks

Time frame: At delivery, up to 28 weeks of gestation

Number of Participants Experiencing Stillbirth

Participants who had a fetus born without signs of life at any gestational age

Time frame: At delivery, up to approximately 40 weeks of gestation

Number of Participants Experiencing Spontaneous Delivery <37 Weeks

Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention

Time frame: At delivery, up to 37 weeks of gestation

Number of Participants Experiencing Spontaneous Delivery <34 Weeks

Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.