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

This study has been terminated.
(The DSMB supported termination of the trial due to slow recruitment.)
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta Identifier:
First received: November 25, 2005
Last updated: April 5, 2010
Last verified: April 2010

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.

Condition Intervention
Fetal Membranes, Premature Rupture
Procedure: Induction of delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Intentional Delivery After Preterm and Prelabor Rupture of Membranes Between 32 and 35 Weeks of Gestation: A Multicentre Randomized and Controlled Trial

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Length of Stay in hospital [ Time Frame: time between birth and readiness for discharge ]

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

Enrollment: 152
Study Start Date: January 2006
Estimated Study Completion Date: September 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Expectant management
Active Comparator: 2
Induction of delivery
Procedure: Induction of delivery
Induction of delivery
Other Name: immediate delivery


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00259519

Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Caritas - Misericordia Hospital
Edmonton, Alberta, Canada, T6R 4H5
Canada, British Columbia
BC Women's Hospital and Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Women's Hospital
Winnipeg, Manitoba, Canada, R3L 0W8
Canada, Ontario
Saint-Joseph Health Care
London, Ontario, Canada, N6A 4V2
Canada, Quebec
Sainte-Justine Hospital
Montreal, Quebec, Canada
Laval University Hospital
Quebec City, Quebec, Canada
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Alberta
Stollery Children's Hospital Foundation
Principal Investigator: Thierry Lacaze-Masmonteil, MD, PhD University of Alberta
Principal Investigator: Radha Chari, MD,FRCPC University of Alberta- Department of Gynecology and Obstetrics
  More Information

Responsible Party: Dr Thierry Lacaze-Masmonteil, University of Alberta - Department of Pediatrics Identifier: NCT00259519     History of Changes
Other Study ID Numbers: N041000314
Study First Received: November 25, 2005
Last Updated: April 5, 2010

Keywords provided by University of Alberta:
premature or preterm birth
neonatal sepsis
Cesarean Section
length of stay

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Wounds and Injuries
Obstetric Labor Complications
Pregnancy Complications processed this record on April 24, 2017