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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00890630
Other study ID # 09-3265
Secondary ID
Status Terminated
Phase Phase 2
First received April 27, 2009
Last updated July 19, 2011
Start date April 2010
Est. completion date July 2011

Study information

Verified date July 2011
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Description:

This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.

The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Singleton Pregnancy

- 37.0 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Intracervical Balloon Catheter
Intracervical insertion of an 80cc Double-Balloon Catheter.
Drug:
Oxytocin
IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.

Locations

Country Name City State
Canada St Joseph's Healthcare Hamilton Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
McMaster University St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility 48 hours No
Secondary Intrapartum Fever 48 Hours Yes
Secondary Duration of Labour 48 hours No
Secondary NICU Admission 0-7 days postpartum Yes
Secondary Chorioamnionitis 48 Hours Yes
Secondary Patient Satisfaction 0-6 weeks Postpartum No
See also
  Status Clinical Trial Phase
Terminated NCT00201656 - Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM) Phase 4
Completed NCT02901795 - Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes
Not yet recruiting NCT00247104 - The Use of Cranberries in Women With Preterm Premature Rupture of Membranes N/A
Not yet recruiting NCT06262308 - Emotional Support for Women Experiencing PPROM N/A
Recruiting NCT02380560 - Myometrial Thickness as a Predictor for the Latency Interval in PPROM N/A
Completed NCT00070746 - Perinatal Infections in Pakistan N/A
Recruiting NCT02997345 - PPROM Registry (Preterm Premature Rupture of Membranes)
Terminated NCT00259519 - Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes N/A
Terminated NCT00290199 - Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture N/A
Recruiting NCT02369601 - PROMComplete for Determination of Rupture of Fetal Membranes
Withdrawn NCT01063686 - The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester N/A
Not yet recruiting NCT00432588 - Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies Phase 1/Phase 2