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

March 23, 2020 updated by: University of Alberta

Effects of Intentional Delivery After Preterm and Prelabor Rupture of Membranes Between 32 and 35 Weeks of Gestation: A Multicentre Randomized and Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Hospital
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Community Hospital
      • Edmonton, Alberta, Canada, T5H3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, T6R 4H5
        • Caritas - Misericordia Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital and Health Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
      • Winnipeg, Manitoba, Canada, R3L 0W8
        • Women's Hospital
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Saint-Joseph Health Care
    • Quebec
      • Montreal, Quebec, Canada
        • Sainte-Justine Hospital
      • Quebec City, Quebec, Canada
        • Laval University Hospital
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with recent PPROM between 31 weeks + 6 days and 35 weeks + 6 days (estimated gestational age based on an ultrasound examination before 18 weeks of gestation), not in labour 24 hours after admission*, will be considered eligible for the study provided the following inclusion criteria (*For patients transferred from a remote level 2 centre to one of the participating sites within the first hours after PPROM, the onset of the 24-hour screening period will be the time of admission in the centre of origin. Patients in Group A will be given their first dose of antenatal steroids before the transfer)
  • Single and otherwise uncomplicated pregnancy
  • Recent history (less than 48 hours) of leaking with the two followings within 24 hours after primary medical assessment: Documentation of fluid from the vagina and Positive Fern test, or positive Nitrazine test, or Positive ACTIM PROM test
  • Antenatal steroids course initiated after the rupture for women with PPROM between 31 + 6 and 33 + 6 weeks
  • Normal fetal heart rate trace using an external ultrasound transducer
  • Written informed consent obtained before inclusion and randomization

Exclusion Criteria:

  • Multiple pregnancy
  • HIV positive mother
  • Active HSV cervical lesions
  • Major fetal anomaly on ultrasound examination performed after admission
  • Intrauterine growth restriction estimated on ultrasound below the 5th percentile or preeclampsia
  • Placenta abruption present at the time of the diagnosis of PPROM or occurring within the first 24 hours after rupture
  • Clinical chorioamnionitis existing before or at the time of the diagnosis of PPROM or developing within the first 24 hours after rupture
  • Non-reassuring fetal testing present at the time of the diagnosis of PPROM or occurring within the first 24 hours after the rupture. It implies that expected criteria for standard fetal assessment parameters have not been met, including the Non-Stress test and the Biophysical profile Score. This will be diagnosed at the discretion of the attending physician.
  • More generally, any maternal or fetal reason for an immediate delivery, either existing at admission or occurring within the 24 hours after admission.
  • Mother refusal or inability to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
Expectant management
ACTIVE_COMPARATOR: 2
Induction of delivery
Procedure: Induction of delivery
Induction of delivery
Other Names:
  • immediate delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of Stay in hospital
Time Frame: time between birth and readiness for discharge
time between birth and readiness for discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
MAIN Score (Morbidity Assessment Index for Newborns)
Time Frame: From birth to discharge
From birth to discharge
Early Onset Neonatal Sepsis
Time Frame: from birth to discharge
from birth to discharge
Clinical and Histological Chorioamnionitis
Time Frame: from birth to discharge
from birth to discharge
Antepartum Length of stay
Time Frame: From diagnosis to delivery
From diagnosis to delivery
C-Section
Time Frame: delivery
delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Stollery Children's Hospital Foundation

Investigators

  • Principal Investigator: Thierry Lacaze-Masmonteil, MD, PhD, University of Alberta
  • Principal Investigator: Radha Chari, MD,FRCPC, University of Alberta- Department of Gynecology and Obstetrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2006

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

November 25, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (ESTIMATE)

November 29, 2005

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N041000314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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