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TerminatedNCT00259519Updated Mar 25, 2020

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

An interventional study of Induction of delivery in Fetal Membranes, Premature Rupture, sponsored by University of Alberta. Terminated at 11 sites in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of Alberta · Not applicable, Interventional, and Treatment

Why this study was terminated
The DSMB supported termination of the trial due to slow recruitment.
Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Sex
Female
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Study 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.

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Conditions studied

  • Fetal Membranes, Premature Rupture

Keywords

  • premature or preterm birth
  • chorioamnionitis
  • neonatal sepsis
  • labour
  • Cesarean Section
  • delivery
  • length of stay
  • pregnancy
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In context

Fetal Membranes, Premature Rupture

142 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 27 are open to participants now.

This study's enrollment of 152 is close to the median of 145 across 86 interventional studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (actual)

Study arms

  • No intervention
    1

    Expectant management

  • Active comparator
    2

    Induction of delivery

    Procedure: Induction of delivery

Interventions

  • ProcedureInduction of delivery

    Induction of delivery

    Also known as: immediate delivery

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What researchers measure

Primary outcomes

  1. Length of Stay in hospital

    Time frame: time between birth and readiness for discharge

Secondary outcomes

  1. MAIN Score (Morbidity Assessment Index for Newborns)

    Time frame: From birth to discharge

  2. Early Onset Neonatal Sepsis

    Time frame: from birth to discharge

  3. Clinical and Histological Chorioamnionitis

    Time frame: from birth to discharge

  4. Antepartum Length of stay

    Time frame: From diagnosis to delivery

  5. C-Section

    Time frame: delivery

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Study locations

11 sites
  • Foothills Hospital
    Calgary, Alberta, Canada
  • Royal Alexandra Hospital
    Edmonton, Alberta T5H3V9, Canada
  • Grey Nuns Community Hospital
    Edmonton, Alberta T6L 5X8, Canada
  • Caritas - Misericordia Hospital
    Edmonton, Alberta T6R 4H5, Canada
  • BC Women's Hospital and Health Centre
    Vancouver, British Columbia V6H 3N1, Canada
  • St. Boniface General Hospital
    Winnipeg, Manitoba R2H 2A6, Canada
  • Women's Hospital
    Winnipeg, Manitoba R3L 0W8, Canada
  • Saint-Joseph Health Care
    London, Ontario N6A 4V2, Canada
  • Sainte-Justine Hospital
    Montreal, Quebec, Canada
  • Laval University Hospital
    Quebec City, Quebec, Canada
  • Royal University Hospital
    Saskatoon, Saskatchewan S7N 0W8, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00259519
Lead sponsor
University of Alberta
Collaborators
Stollery Children's Hospital Foundation
Responsible party
Sponsor
First posted
Nov 29, 2005
Start date
Jan 2006
Primary completion
Mar 2010
Completion
Mar 2020
Last update
Mar 25, 2020

Study contacts

Thierry Lacaze-Masmonteil, MD, PhD
principal investigator · University of Alberta
Radha Chari, MD,FRCPC
principal investigator · University of Alberta- Department of Gynecology and Obstetrics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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