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 36 weeks.

The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 36 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

Further study details as provided by University of Alberta:

Primary Outcomes: NICU Length of Stay (duration between birth and "readiness for discharge")
Secondary Outcomes: Main secondary outcomes are:; - MAIN Score (Morbidity Assessment Index for Newborns); - Early Onset Neonatal Sepsis; - Clinical and Histological Chorioamnionitis; - Antepartum Length of stay; - C-Section
Expected Total Enrollment:  360

Genders Eligible for Study:  Female

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00259519

Nathalie Lacaze, MD, PhD      780-407-3786    nathalielacaze@cha.ab.ca

Canada, Alberta
      Royal Alexandra Hospital, Edmonton,  Alberta,  T5H3V9,  Canada
      Grey Nuns Community Hospital, Edmonton,  Alberta,  T6L 5X8,  Canada
Canada, British Columbia
      BC Women''''s Hospital and Health Centre, Vancouver,  British Columbia,  V6H 3N1,  Canada
Canada, Manitoba
      Women''''s Hospital, Winnipeg,  Manitoba,  R3L 0W8,  Canada
      St. Boniface General Hospital, Winnipeg,  Manitoba,  R2H 2A6,  Canada
Canada, Saskatchewan
      Royal University Hospital, Saskatoon,  Saskatchewan,  S7N 0W8,  Canada

Study chairs or principal investigators

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

Study ID Numbers:  N041000314
Last Updated:  December 8, 2005
Record first received:  November 25, 2005
ClinicalTrials.gov Identifier:  NCT00259519
Health Authority: Canada: University of Alberta HREB
ClinicalTrials.gov processed this record on 2006-01-10