Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth (VP)
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|ClinicalTrials.gov Identifier: NCT02970552|
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|PreTerm Birth||Drug: Vaginal Progesterone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Z 31606 - A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||November 13, 2018|
|Actual Study Completion Date :||November 13, 2018|
Active Comparator: Vaginal Progesterone
Daily self-administered vaginal progesterone
Drug: Vaginal Progesterone
200 mg micronized vaginal progesterone suppository
Placebo Comparator: Placebo
Daily self-administered indistinguishable placebo
Indistinguishable placebo vaginal suppository
- Proportion of women with adequate adherence [ Time Frame: daily for 16 weeks ]Adequate adherence to study product (at least 80% of prescribed study doses), defined as proper self-administration will be measured by a dye stain assay of returned applicators.
- Acceptability of use of VP [ Time Frame: at enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation ]Semi-structured interviews will be held with a random sample of participants who enroll and who decline enrollment.
- Preliminary efficacy [ Time Frame: 34 and 37 gestational weeks ]Proportion of participants in each arm delivering before 37 and before 34 completed weeks of gestation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970552
|Kamwala District Health Centre|
|Principal Investigator:||Jeffrey Stringer, MD||University of North Carolina, Chapel Hill|