Fetal Membranes, Premature Rupture
Conditions
Keywords
premature or preterm birth, chorioamnionitis, neonatal sepsis, labour, Cesarean Section, delivery, length of stay, pregnancy
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.
Interventions
PROCEDUREInduction of delivery
Induction of delivery
Sponsors
Stollery Children's Hospital Foundation
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Stay in hospital | time between birth and readiness for discharge |
Secondary
| Measure | Time frame |
|---|---|
| MAIN Score (Morbidity Assessment Index for Newborns) | From birth to discharge |
| Early Onset Neonatal Sepsis | from birth to discharge |
| Clinical and Histological Chorioamnionitis | from birth to discharge |
| Antepartum Length of stay | From diagnosis to delivery |
| C-Section | delivery |
Countries
Canada
Outcome results
None listed