Balloon Induction of Labor in PROM for TOLAC (BILROM-TOLAC)

November 8, 2018 updated by: Gil Gutvirtz MD, Soroka University Medical Center

Mechanical Induction of Labor in Women With Previous Cesarean Section and Premature Rupture of Membranes Who Desire TOLAC: A Prospective Randomized Study

A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Be'er Sheva, Israel
        • Recruiting
        • Soroka University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Only patients who meet the following criteria will be approached.

  1. Singleton Pregnancy
  2. Previous single cesarean section
  3. At least 12 months have elapsed since the previous caesarean delivery
  4. Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
  5. Ruptured membranes have occurred ≤24 hours prior to inclusion in the study.
  6. Vertex presentation well applied to the cervix
  7. Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
  8. Absence of significant and regular uterine contraction (<3/10Min).
  9. Willingness to comply with the protocol for the duration of the study.
  10. Have signed an informed consent (including a TOLAC consent form).

Exclusion Criteria:

Patients having any of the following conditions will be excluded from the study:

  1. Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery < 12 months).
  2. Regular uterine contractions (>3/10Min).
  3. Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion.
  4. Meconium stained amniotic fluid.
  5. Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
  6. Suspected placental abruption or a significant hemorrhage.
  7. Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double balloon catheter for induction of labor
in this group a trans-cervical double balloon catheter will be inserted. Following device insertion, 20 minutes of external monitoring is performed. The patient will be transferred to the Ob/Gyn ward for hospitalization. 12 hours after insertion of the device the balloons are deflated and the device removed. At this stage the patient is assessed for a second Bishop score and expectant management is resuming.
Device: Double Balloon catheter for induction of labor
With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh.
Other Names:
  • Atad Ripener Device
No Intervention: Expectant management
Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vaginal birth after cesarean (VBAC) rates
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
PROM to delivery interval (time)
Time Frame: 5 days
5 days
intrapartum and post-partum infection rates
Time Frame: 5 days
5 days
Cesarean section rates
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR-0019-17-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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