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

University of Alberta

Status

Terminated

Conditions

Fetal Membranes, Premature Rupture

Treatments

Procedure: Induction of delivery

Study type

Interventional

Funder types

Other

Identifiers

NCT00259519

N041000314

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

Female

Volunteers

No Healthy Volunteers

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