Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes

NCT00259519 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2020-03-25

No results posted yet for this study

Summary

Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.

The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated with PPROM-related complications without increasing the morbidity associated with a shortened pregnancy.

Conditions

  • Fetal Membranes, Premature Rupture

Interventions

PROCEDURE

Induction of delivery

Induction of delivery

Sponsors & Collaborators

  • Stollery Children's Hospital Foundation

    collaborator OTHER
  • University of Alberta

    lead OTHER

Principal Investigators

  • Thierry Lacaze-Masmonteil, MD, PhD · University of Alberta

  • Radha Chari, MD,FRCPC · University of Alberta- Department of Gynecology and Obstetrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-03-31
Completion
2020-03-31

Countries

  • Canada

Study Locations

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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 NCT00259519 on ClinicalTrials.gov