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Oral Progesterone for Prevention of Preterm Birth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180296
First Posted: August 12, 2010
Last Update Posted: March 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fetal Medicine Foundation
August 10, 2010
August 12, 2010
June 22, 2011
July 21, 2011
March 5, 2012
November 2006
January 2009   (Final data collection date for primary outcome measure)
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.
Rate of Recurrent Preterm Birth
Complete list of historical versions of study NCT01180296 on ClinicalTrials.gov Archive Site
Serum Progesterone Levels [ Time Frame: At approximately 28 weeks' gestation ]
Same as current
Not Provided
Not Provided
 
Oral Progesterone for Prevention of Preterm Birth
Prevention of Recurrent Preterm Birth With Micronized Progesterone
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Preterm Birth
  • Drug: oral micronized progesterone
    400 mg oral micronized progesterone nightly from 16 to 34 weeks vs placebo
    Other Name: Prometrium(TM)
  • Drug: Identical Placebo tablet
    placebo taking nightly from 16 to 34 weeks
  • Experimental: Progesterone Group
    Intervention: Drug: oral micronized progesterone
  • Placebo Comparator: Placebo
    Intervention: Drug: Identical Placebo tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01180296
MVH-MP-Pilot-RCT
No
Not Provided
Not Provided
David S. McKenna, Fetal Medicine Foundation/USA
Fetal Medicine Foundation
Not Provided
Principal Investigator: David S McKenna, MD Fetal Medicine Foundation/USA
Fetal Medicine Foundation
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP