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Oral Progesterone for Prevention of Preterm Birth

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
oral micronized progesterone
Identical Placebo tablet
Sponsored by
Fetal Medicine Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Preterm birth, prevention, progesterone, oral

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Miami Valley HospitaL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progesterone Group

Placebo

Arm Description

Oral Micronized Progesterone

Identical Placebo Tablet

Outcomes

Primary Outcome Measures

Rate of Recurrent Preterm Birth
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

Secondary Outcome Measures

Secondary Outcomes
Serum progesterone levels

Full Information

First Posted
August 10, 2010
Last Updated
February 13, 2019
Sponsor
Fetal Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01180296
Brief Title
Oral Progesterone for Prevention of Preterm Birth
Official Title
Prevention of Recurrent Preterm Birth With Micronized Progesterone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fetal Medicine Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm birth, prevention, progesterone, oral

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone Group
Arm Type
Experimental
Arm Description
Oral Micronized Progesterone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical Placebo Tablet
Intervention Type
Drug
Intervention Name(s)
oral micronized progesterone
Other Intervention Name(s)
Prometrium(TM)
Intervention Description
oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
Intervention Type
Drug
Intervention Name(s)
Identical Placebo tablet
Other Intervention Name(s)
Placebo
Intervention Description
Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
Primary Outcome Measure Information:
Title
Rate of Recurrent Preterm Birth
Description
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
Time Frame
Prior to 37 weeks' gestation
Secondary Outcome Measure Information:
Title
Secondary Outcomes
Description
Serum progesterone levels
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S McKenna, MD
Organizational Affiliation
Fetal Medicine Foundation/USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Valley HospitaL
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States

12. IPD Sharing Statement

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Oral Progesterone for Prevention of Preterm Birth

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