Phase 3
Completed N=36
Oral Progesterone for Prevention of Preterm Birth
Source: ClinicalTrials.gov NCT01180296 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Rate of Recurrent Preterm Birth — 5; 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Recurrent Preterm Birth |
5; 8 | — |
| SECONDARY Secondary Outcomes |
122.6; 90.1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01180296). 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.