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Oral Progesterone for Prevention of Preterm Birth

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.
 
ClinicalTrials.gov Identifier: NCT01180296
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : July 21, 2011
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
David S. McKenna, Fetal Medicine Foundation

Tracking Information
First Submitted Date  ICMJE August 10, 2010
First Posted Date  ICMJE August 12, 2010
Results First Submitted Date  ICMJE June 22, 2011
Results First Posted Date  ICMJE July 21, 2011
Last Update Posted Date February 18, 2019
Study Start Date  ICMJE November 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Rate of Recurrent Preterm Birth
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Secondary Outcomes [ Time Frame: Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group ]
Serum progesterone levels
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Serum Progesterone Levels [ Time Frame: At approximately 28 weeks' gestation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Progesterone for Prevention of Preterm Birth
Official Title  ICMJE Prevention of Recurrent Preterm Birth With Micronized Progesterone
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preterm Birth
Intervention  ICMJE
  • Drug: oral micronized progesterone
    oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
    Other Name: Prometrium(TM)
  • Drug: Identical Placebo tablet
    Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Progesterone Group
    Oral Micronized Progesterone
    Intervention: Drug: oral micronized progesterone
  • Placebo Comparator: Placebo
    Identical Placebo Tablet
    Intervention: Drug: Identical Placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2012)
36
Original Actual Enrollment  ICMJE
 (submitted: August 11, 2010)
33
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180296
Other Study ID Numbers  ICMJE MVH-MP-Pilot-RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David S. McKenna, Fetal Medicine Foundation
Study Sponsor  ICMJE Fetal Medicine Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S McKenna, MD Fetal Medicine Foundation/USA
PRS Account Fetal Medicine Foundation
Verification Date February 2019

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