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Oral Progesterone for Prevention of Preterm Birth

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ClinicalTrials.gov Identifier: NCT01180296
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : July 21, 2011
Last Update Posted : March 5, 2012
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Preterm Birth Drug: oral micronized progesterone Drug: Identical Placebo tablet Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Preterm Birth With Micronized Progesterone
Study Start Date : November 2006
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Serum Progesterone Levels [ Time Frame: At approximately 28 weeks' gestation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David S. McKenna, Fetal Medicine Foundation/USA
ClinicalTrials.gov Identifier: NCT01180296     History of Changes
Other Study ID Numbers: MVH-MP-Pilot-RCT
First Posted: August 12, 2010    Key Record Dates
Results First Posted: July 21, 2011
Last Update Posted: March 5, 2012
Last Verified: March 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
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs