Oral Progesterone for Prevention of Preterm Birth
Phase 3
Completed
- Conditions
- Preterm Birth
- Interventions
- Drug: Identical Placebo tablet
- Registration Number
- NCT01180296
- Lead Sponsor
- Fetal Medicine Foundation
- Brief Summary
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
- Detailed Description
To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
- pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks' gestation.
Exclusion Criteria
- multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progesterone Group oral micronized progesterone Oral Micronized Progesterone Placebo Identical Placebo tablet Identical Placebo Tablet
- Primary Outcome Measures
Name Time Method Rate of Recurrent Preterm Birth Prior to 37 weeks' gestation Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
- Secondary Outcome Measures
Name Time Method Secondary Outcomes Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group Serum progesterone levels
Trial Locations
- Locations (1)
Miami Valley HospitaL
🇺🇸Dayton, Ohio, United States