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Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

NCT01050647 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-04-09

Study results available
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Summary

Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).

Conditions

  • Pregnancy Complications

Interventions

DRUG

17-Hydroxyprogesterone Caproate

Weekly injections of 17-hydroxyprogesterone caproate.

OTHER

Caster Oil injections

Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Sponsors & Collaborators

Principal Investigators

  • Yasser Y El-Sayed, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01050647 on ClinicalTrials.gov