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Oral Progesterone for Prevention of Preterm Birth

This study has been completed.
Sponsor:
Information provided by:
Fetal Medicine Foundation
ClinicalTrials.gov Identifier:
NCT01180296
First received: August 10, 2010
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Preterm Birth With Micronized Progesterone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fetal Medicine Foundation:

Primary Outcome Measures:
  • Rate of Recurrent Preterm Birth [ Time Frame: Prior to 37 weeks' gestation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180296

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

No publications provided

Responsible Party: David S. McKenna, Fetal Medicine Foundation/USA
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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
Progesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013