Phase 3
Completed N=800
Improving Pregnancy Outcomes With Progesterone
Pre-term Birth · HIV-1 Infection
Source: ClinicalTrials.gov NCT03297216 ↗
Enrolled (actual)
800
Serious AEs
10.4%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Experiencing Preterm Births or Stillbirths — 36; 36 Participants
◆ Published Evidence
Established
28citations · ~6 / year
Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial.
Summary
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Linked Publications (2)
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Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial.
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Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Preterm Births or Stillbirths |
36; 36 | — |
| SECONDARY Number of Participants Experiencing Preterm Birth <37 Weeks |
31; 35 | — |
| SECONDARY Number of Participants Experiencing Preterm Birth <34 Weeks |
14; 16 | — |
| SECONDARY Number of Participants Experiencing Preterm Birth <28 Weeks |
3; 5 | — |
| SECONDARY Number of Participants Experiencing Stillbirth |
10; 11 | — |
| SECONDARY Number of Participants Experiencing Spontaneous Delivery <37 Weeks |
25; 26 | — |
| SECONDARY Number of Participants Experiencing Spontaneous Delivery <34 Weeks |
10; 11 | — |
| SECONDARY Number of Participants Experiencing Spontaneous Delivery <28 Weeks |
3; 4 | — |
| SECONDARY Number of Infants With Birth Weight <10th Percentile for Gestational Age |
95; 93 | — |
| SECONDARY Number of Infants With Birth Weight <3rd Percentile for Gestational Age |
28; 47 | — |
| SECONDARY Number of Infants Who Experienced Maternal-to-Child HIV Transmission |
1; 1 | — |
| SECONDARY Number of Neonatal Deaths |
14; 7 | — |
| SECONDARY Number of Infants With 1-minute Apgar Score <7 |
12; 9 | — |
| SECONDARY Number of Infants With 5-minute Apgar Score <7 |
7; 2 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03297216) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.