NCT00890630

Brief Summary

The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

April 27, 2009

Last Update Submit

July 19, 2011

Conditions

Fetal Membranes, Premature RuptureInduced Labor

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    48 hours

Secondary Outcomes (5)

  • Intrapartum Fever

    48 Hours

  • Duration of Labour

    48 hours

  • NICU Admission

    0-7 days postpartum

  • Chorioamnionitis

    48 Hours

  • Patient Satisfaction

    0-6 weeks Postpartum

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Induction of Labour with Oxytocin Alone

Drug: Oxytocin

Intracervical Catheter

EXPERIMENTAL

Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.

Procedure: Intracervical Balloon CatheterDrug: Oxytocin

Interventions

Intracervical Balloon CatheterPROCEDURE

Intracervical insertion of an 80cc Double-Balloon Catheter.

Intracervical Catheter
OxytocinDRUG

IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.

Intracervical CatheterOxytocin

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton Pregnancy
  • and 41.0 gestational age
  • Confirmed Rupture of Membranes
  • Group B Streptococcus Negative
  • Cephalic Presentation
  • Absence of contractions for at least 60 minutes following rupture
  • Absence of contractions at time of enrolment

You may not qualify if:

  • Contraindication to Vaginal Delivery
  • Previous Uterine Surgery, including Caesarean Section
  • Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery
  • Documented history of cervical incompetence
  • High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer.
  • Immunosuppressed State
  • Active Vaginal Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Location

Related Publications (2)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

  • Costescu DJ, Cullimore AJ. Lessons learned from a resident-led clinical trial in obstetrics. Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13.

    PMID: 23766376DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dustin Costescu, MD, BSc

    McMaster University, Department of Obstetrics and Gynaecology

    PRINCIPAL INVESTIGATOR

  • Amie Cullimore, MD BSc BEd

    McMaster University, Department of Obstetrics and Gynaecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 30, 2009

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

CA(1)