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Oral Progesterone for Prevention of Preterm Birth

Information source: Fetal Medicine Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Birth

Intervention: oral micronized progesterone (Drug); Identical Placebo tablet (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Fetal Medicine Foundation

Official(s) and/or principal investigator(s):
David S McKenna, MD, Principal Investigator, Affiliation: Fetal Medicine Foundation/USA

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.

Clinical Details

Official title: Prevention of Recurrent Preterm Birth With Micronized Progesterone

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Rate of Recurrent Preterm Birth

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Locations and Contacts

Miami Valley HospitaL, Dayton, Ohio 45409, United States
Additional Information

Starting date: November 2006
Last updated: March 2, 2012

Page last updated: August 23, 2015

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