Clinical trial NCT00259519: Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fetal Membranes, Premature Rupture
Keywords: premature or preterm birth
chorioamnionitis
neonatal sepsis
labour
Cesarean Section
delivery
length of stay
pregnancy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Stollery Children's Hospital Foundation
First posted: 2005-11-29
Enrollment: 152
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Length of Stay in hospital
timeFrame: time between birth and readiness for discharge
Secondary outcomes:
measure: MAIN Score (Morbidity Assessment Index for Newborns)
timeFrame: From birth to discharge
measure: Early Onset Neonatal Sepsis
timeFrame: from birth to discharge
measure: Clinical and Histological Chorioamnionitis
timeFrame: from birth to discharge
measure: Antepartum Length of stay
timeFrame: From diagnosis to delivery
measure: C-Section
timeFrame: delivery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Caritas - Misericordia Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Women's Hospital and Health Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Women's Hospital
state: Manitoba
city: London
country: Canada
facility: Saint-Joseph Health Care
state: Ontario
city: Montreal
country: Canada
facility: Sainte-Justine Hospital
state: Quebec
city: Quebec City
country: Canada
facility: Laval University Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Alberta
name: Thierry Lacaze-Masmonteil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta- Department of Gynecology and Obstetrics
name: Radha Chari, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: