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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259519
Recruitment Status : Terminated (The DSMB supported termination of the trial due to slow recruitment.)
First Posted : November 29, 2005
Last Update Posted : March 25, 2020
Stollery Children's Hospital Foundation
Information provided by (Responsible Party):
University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Fetal Membranes, Premature Rupture Procedure: Induction of delivery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
No Intervention: 1
Expectant management
Active Comparator: 2
Induction of delivery
Procedure: Induction of delivery
Induction of delivery
Other Name: immediate delivery

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259519

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

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Responsible Party: University of Alberta Identifier: NCT00259519    
Other Study ID Numbers: N041000314
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Keywords provided by University of Alberta:
premature or preterm birth
neonatal sepsis
Cesarean Section
length of stay
Additional relevant MeSH terms:
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Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries