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.)
Sponsor:
Collaborator:
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00259519
First received: November 25, 2005
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MAIN Score (Morbidity Assessment Index for Newborns) [ Time Frame: From birth to discharge ] [ Designated as safety issue: No ]
  • Early Onset Neonatal Sepsis [ Time Frame: from birth to discharge ] [ Designated as safety issue: No ]
  • Clinical and Histological Chorioamnionitis [ Time Frame: from birth to discharge ] [ Designated as safety issue: No ]
  • Antepartum Length of stay [ Time Frame: From diagnosis to delivery ] [ Designated as safety issue: No ]
  • C-Section [ Time Frame: delivery ] [ Designated as safety issue: Yes ]

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259519

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
Caritas - Misericordia Hospital
Edmonton, Alberta, Canada, T6R 4H5
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
BC Women's Hospital and Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Manitoba
Women's Hospital
Winnipeg, Manitoba, Canada, R3L 0W8
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
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
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
  More Information

No publications provided

Responsible Party: Dr Thierry Lacaze-Masmonteil, University of Alberta - Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00259519     History of Changes
Other Study ID Numbers: N041000314
Study First Received: November 25, 2005
Last Updated: April 5, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014