NCT01180296

Oral Progesterone for Prevention of Preterm Birth

Prevention of Recurrent Preterm Birth With Micronized Progesterone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Fetal Medicine Foundation · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DRUG	oral micronized progesterone	oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
DRUG	Identical Placebo tablet	Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2010-08-12
• Last updated: 2019-02-18
• Results posted: 2011-07-21

Locations

1 site across 1 country: United States