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Oral Progesterone for Prevention of Preterm Birth

NCT01180296 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-18

Study results available
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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.

Conditions

Interventions

DRUG

oral micronized progesterone

oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks

DRUG

Identical Placebo tablet

Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Sponsors & Collaborators

  • Fetal Medicine Foundation

    lead OTHER

Principal Investigators

  • David S McKenna, MD · Fetal Medicine Foundation/USA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180296 on ClinicalTrials.gov