Status:
TERMINATED
Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Stollery Children's Hospital Foundation
Conditions:
Fetal Membranes, Premature Rupture
Eligibility:
FEMALE
Phase:
NA
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 3...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00259519
Start Date
January 1 2006
End Date
March 1 2020
Last Update
March 25 2020
Active Locations (11)
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1
Foothills Hospital
Calgary, Alberta, Canada
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
3
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
4
Caritas - Misericordia Hospital
Edmonton, Alberta, Canada, T6R 4H5