Title
Oral Progesterone for Prevention of Preterm Birth
Prevention of Recurrent Preterm Birth With Micronized Progesterone
Phase
Phase 3Lead Sponsor
Fetal Medicine FoundationStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Preterm BirthIntervention/Treatment
progesterone ...Study Participants
36To 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.
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.
oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
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.
| Event Type | Organ System | Event Term |
|---|
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
Serum progesterone levels
