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

Fetal Membranes, Premature Rupture Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00259519
• Other study ID #: N041000314
• Status: Terminated
• Phase: N/A
• Start date: January 2006
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: March 2020
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Rupture

Intervention

Procedure:
• Induction of delivery
Induction of delivery

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	Caritas - Misericordia Hospital	Edmonton	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Saint-Joseph Health Care	London	Ontario
Canada	Sainte-Justine Hospital	Montreal	Quebec
Canada	Laval University Hospital	Quebec City	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	BC Women's Hospital and Health Centre	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Canada	Women's Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Stollery Children's Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay in hospital		time between birth and readiness for discharge
Secondary	MAIN Score (Morbidity Assessment Index for Newborns)		From birth to discharge
Secondary	Early Onset Neonatal Sepsis		from birth to discharge
Secondary	Clinical and Histological Chorioamnionitis		from birth to discharge
Secondary	Antepartum Length of stay		From diagnosis to delivery
Secondary	C-Section		delivery