Oral Progesterone for Prevention of Preterm Birth

Preterm Birth Clinical Trial

Official title:

Prevention of Recurrent Preterm Birth With Micronized Progesterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180296
• Other study ID #: MVH-MP-Pilot-RCT
• Status: Completed
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: January 2009

Study information

• Verified date: February 2019
• Source: Fetal Medicine Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• oral micronized progesterone
oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
• Identical Placebo tablet
Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Locations

Country	Name	City	State
United States	Miami Valley HospitaL	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Fetal Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Recurrent Preterm Birth	Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.	Prior to 37 weeks' gestation
Secondary	Secondary Outcomes	Serum progesterone levels	Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group