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

Primary Purpose

Fetal Membranes, Premature Rupture

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Induction of delivery
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Membranes, Premature Rupture focused on measuring premature or preterm birth, chorioamnionitis, neonatal sepsis, labour, Cesarean Section, delivery, length of stay, pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Foothills Hospital
  • Royal Alexandra Hospital
  • Grey Nuns Community Hospital
  • Caritas - Misericordia Hospital
  • BC Women's Hospital and Health Centre
  • St. Boniface General Hospital
  • Women's Hospital
  • Saint-Joseph Health Care
  • Sainte-Justine Hospital
  • Laval University Hospital
  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Expectant management

Induction of delivery

Outcomes

Primary Outcome Measures

Length of Stay in hospital

Secondary Outcome Measures

MAIN Score (Morbidity Assessment Index for Newborns)
Early Onset Neonatal Sepsis
Clinical and Histological Chorioamnionitis
Antepartum Length of stay
C-Section

Full Information

First Posted
November 25, 2005
Last Updated
March 23, 2020
Sponsor
University of Alberta
Collaborators
Stollery Children's Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00259519
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
The DSMB supported termination of the trial due to slow recruitment.
Study Start Date
January 2006 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Stollery Children's Hospital Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Membranes, Premature Rupture
Keywords
premature or preterm birth, chorioamnionitis, neonatal sepsis, labour, Cesarean Section, delivery, length of stay, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Expectant management
Arm Title
2
Arm Type
Active Comparator
Arm Description
Induction of delivery
Intervention Type
Procedure
Intervention Name(s)
Induction of delivery
Other Intervention Name(s)
immediate delivery
Intervention Description
Induction of delivery
Primary Outcome Measure Information:
Title
Length of Stay in hospital
Time Frame
time between birth and readiness for discharge
Secondary Outcome Measure Information:
Title
MAIN Score (Morbidity Assessment Index for Newborns)
Time Frame
From birth to discharge
Title
Early Onset Neonatal Sepsis
Time Frame
from birth to discharge
Title
Clinical and Histological Chorioamnionitis
Time Frame
from birth to discharge
Title
Antepartum Length of stay
Time Frame
From diagnosis to delivery
Title
C-Section
Time Frame
delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lacaze-Masmonteil, MD, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Radha Chari, MD,FRCPC
Organizational Affiliation
University of Alberta- Department of Gynecology and Obstetrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H3V9
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Caritas - Misericordia Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6R 4H5
Country
Canada
Facility Name
BC Women's Hospital and Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Women's Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 0W8
Country
Canada
Facility Name
Saint-Joseph Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Sainte-Justine Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Laval University Hospital
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

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

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