Improving Pregnancy Outcomes With Progesterone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-07

Study Completion Date

2020-08-06

Brief Summary

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

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Detailed Description

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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

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Pre-term Birth HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase III, double-masked, placebo-controlled, randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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250 mg 17P

weekly intramuscular injection of 250mg 17P

Group Type ACTIVE_COMPARATOR

17P

Intervention Type DRUG

Synthetic progestin

Placebo

weekly intramuscular injection of indistinguishable placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Non-active placebo comparator

Interventions

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17P

Synthetic progestin

Intervention Type DRUG

Placebo

Non-active placebo comparator

Intervention Type OTHER

Other Intervention Names

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17-alpha hydroxyprogesterone caproate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No