Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02970552
• Date of registration: 17/11/2016
• Prospective Registration: Yes
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth VP
• Scientific title: A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
• Date of first enrolment: July 1, 2017
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02970552
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Zambia

Contacts

• Name: Jeffrey Stringer, MD
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 18 years of age or older

2. viable intrauterine pregnancy confirmed by ultrasound

3. presentation to antenatal care prior to 24 weeks gestation

4. antibody-confirmed HIV-1 infection

5. initiating or continuing ART treatment in pregnancy

6. ability and willingness to provide written informed consent

7. willing to adhere to study visit schedule

Exclusion Criteria:

1. multiple gestation

2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or
cervical length <20mm on screening ultrasound)

3. planned or in situ cervical cerclage

4. evidence of threatened abortion, preterm labor, or ruptured membranes

5. major fetal anomaly detected on screening ultrasound

6. known uterine anomaly

7. known or suspected allergy or contraindication to VP or placebo components



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

PreTerm Birth

Intervention(s)

Drug: Placebo

Drug: Vaginal Progesterone

Primary Outcome(s)

Adequate Adherence to Study Product [Time Frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks]

Secondary Outcome(s)

Stillbirth [Time Frame: Visit 10.0 (Delivery)]

Preliminary Efficacy [Time Frame: Visit 10.0 (Delivery)]

Sensitivity, Specificity, and Predictive Value of Dose Diaries [Time Frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks]

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) [Time Frame: Late in pregnancy or postpartum]

Birth Weight [Time Frame: Visit 10.0 (Delivery)]

Acceptability of a Vaginal Medication to Prevent Preterm Birth [Time Frame: Visit 9.0 (36 weeks of gestation)]

Ascertainment of Date of Delivery and Infant Vital Status [Time Frame: Visit 10.0 (Delivery)]

Acceptability of Use of Vaginal Progesterone (VP) [Time Frame: At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation]

Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study [Time Frame: Late in pregnancy or postpartum]

Reported Barriers to Adherence to Study Product [Time Frame: Visit 9.0 (36 weeks of gestation)]

Enrollment of Eligible Participants [Time Frame: Screening through Enrollment]

Adverse Events [Time Frame: Enrollment through Visit 10.0 (Delivery)]

Secondary ID(s)

1R21HD090987-01

16-2174

Z 31606

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results

• Results available: Yes
• Date Posted: 06/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02970552