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Oral Progesterone for Prevention of Preterm Birth

This study has been completed.
Information provided by:
Fetal Medicine Foundation Identifier:
First received: August 10, 2010
Last updated: March 2, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Preterm Birth
Drug: oral micronized progesterone
Drug: Identical Placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Preterm Birth With Micronized Progesterone

Resource links provided by NLM:

Further study details as provided by Fetal Medicine Foundation:

Primary Outcome Measures:
  • Rate of Recurrent Preterm Birth [ Time Frame: Prior to 37 weeks' gestation ]
    Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

Secondary Outcome Measures:
  • Serum Progesterone Levels [ Time Frame: At approximately 28 weeks' gestation ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone Group Drug: oral micronized progesterone
400 mg oral micronized progesterone nightly from 16 to 34 weeks vs placebo
Other Name: Prometrium(TM)
Placebo Comparator: Placebo Drug: Identical Placebo tablet
placebo taking nightly from 16 to 34 weeks

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01180296

United States, Ohio
Miami Valley HospitaL
Dayton, Ohio, United States, 45409
Sponsors and Collaborators
Fetal Medicine Foundation
Principal Investigator: David S McKenna, MD Fetal Medicine Foundation/USA
  More Information

Responsible Party: David S. McKenna, Fetal Medicine Foundation/USA Identifier: NCT01180296     History of Changes
Other Study ID Numbers: MVH-MP-Pilot-RCT
Study First Received: August 10, 2010
Results First Received: June 22, 2011
Last Updated: March 2, 2012

Keywords provided by Fetal Medicine Foundation:
Preterm birth, prevention, progesterone, oral

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017