Phase 4
Completed N=140
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
Source: ClinicalTrials.gov NCT02970552 ↗Enrolled (actual)
140
Serious AEs
3.6%
Results posted
Feb 2020
Primary outcomePrimary: Adequate Adherence to Study Product — 62; 63 Participants
◆ Published Evidence
Emerging
5citations · ~1 / year
Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol.
Summary
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.
Linked Publications
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Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adequate Adherence to Study Product |
62; 63 | — |
| SECONDARY Acceptability of Use of Vaginal Progesterone (VP) |
— | — |
| SECONDARY Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study |
7; 1; 0; 0; 19; 11 | — |
| SECONDARY Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) |
15; 6; 9; 3; 19; 10 | — |
| SECONDARY Acceptability of a Vaginal Medication to Prevent Preterm Birth |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Reported Barriers to Adherence to Study Product |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Sensitivity, Specificity, and Predictive Value of Dose Diaries |
0.999; 0.571; 0.985; 0.975 | — |
| SECONDARY Enrollment of Eligible Participants |
154; 140 | — |
| SECONDARY Ascertainment of Date of Delivery and Infant Vital Status |
67; 67 | — |
| SECONDARY Preliminary Efficacy |
9; 10; 8; 10; 5; 6 | — |
| SECONDARY Birth Weight |
9; 12 | — |
| SECONDARY Stillbirth |
2; 2 | — |
| SECONDARY Adverse Events |
1; 0; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- viable intrauterine pregnancy confirmed by ultrasound
- presentation to antenatal care prior to 24 weeks gestation
- antibody-confirmed HIV-1 infection
- initiating or continuing ART treatment in pregnancy
- ability and willingness to provide written informed consent
- willing to adhere to study visit schedule
Exclusion Criteria
- multiple gestation
- non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
- planned or in situ cervical cerclage
- evidence of threatened abortion, preterm labor, or ruptured membranes
- major fetal anomaly detected on screening ultrasound
- known uterine anomaly
- known or suspected allergy or contraindication to VP or placebo components
Data sourced from ClinicalTrials.gov (NCT02970552) 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.