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

NCT00259519 | Terminated DMC

• 1 other identifier: N041000314
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 11

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.

Conditions

Fetal Membranes, Premature Rupture

Keywords

premature or preterm birth; chorioamnionitis; neonatal sepsis; labour; Cesarean Section; delivery; length of stay; pregnancy

Outcome Measures

Primary Outcomes (1)

• Length of Stay in hospital

  time between birth and readiness for discharge

Secondary Outcomes (5)

• 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

Study Arms (2)

1

NO INTERVENTION

Expectant management

2

ACTIVE COMPARATOR

Induction of delivery

Procedure: Induction of delivery

Interventions

Induction of delivery PROCEDURE

Induction of delivery

Also known as: immediate delivery

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Stollery Children's Hospital Foundation: collaborator

Study Sites (11)

Foothills Hospital

Calgary, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H3V9, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Caritas - Misericordia Hospital

Edmonton, Alberta, T6R 4H5, Canada

Location

BC Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Women's Hospital

Winnipeg, Manitoba, R3L 0W8, Canada

Location

Saint-Joseph Health Care

London, Ontario, N6A 4V2, Canada

Location

Sainte-Justine Hospital

Montreal, Quebec, Canada

Location

Laval University Hospital

Québec, Quebec, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Premature Birth; Chorioamnionitis; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Fetal Diseases; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sepsis; Infections; Infant, Newborn, Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry Lacaze-Masmonteil, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Radha Chari, MD,FRCPC

  University of Alberta- Department of Gynecology and Obstetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2005
• First Posted: November 29, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (11)