Phase 3 N=36 Randomized Quadruple-blind Prevention

Oral Progesterone for Prevention of Preterm Birth

Preterm Birth

Bottom Line

View on ClinicalTrials.gov: NCT01180296 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Rate of Recurrent Preterm Birth — 5; 8 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: oral micronized progesterone (Drug); Identical Placebo tablet (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Fetal Medicine Foundation
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Recurrent Preterm Birth	5; 8	—
SECONDARY Secondary Outcomes	122.6; 90.1	—

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.

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.

View full record on ClinicalTrials.gov →

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.