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

Primary Purpose

Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn, Prelabor Rupture of Membranes

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Double Balloon catheter for induction of labor

About this trial

This is an interventional treatment trial for Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn focused on measuring Induction of labor, Previous cesarean delivery, Trial of labor after cesarean, Prelabor rupture of membranes, balloon induction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Only patients who meet the following criteria will be approached.

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

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

Sites / Locations

Soroka University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Double balloon catheter for induction of labor

Expectant management

Arm Description

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.

Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.

Outcomes

Primary Outcome Measures

Vaginal birth after cesarean (VBAC) rates

Secondary Outcome Measures

PROM to delivery interval (time)

intrapartum and post-partum infection rates

Cesarean section rates

Full Information

NCT ID

NCT03399266

First Posted

January 8, 2018

Last Updated

November 8, 2018

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03399266

Brief Title

Balloon Induction of Labor in PROM for TOLAC

Acronym

BILROM-TOLAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn, Prelabor Rupture of Membranes

Keywords

Induction of labor, Previous cesarean delivery, Trial of labor after cesarean, Prelabor rupture of membranes, balloon induction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

200 pregnant women with one previous cesarean section and PROM along with an unfavourable cervix (Bishop Score ≤ 6) are expected to be entered into the study. All eligible women will be presented with the study protocol by a study coordinator.The following screening medical procedures will be completed: Medical and gynecological history, physical and vaginal speculum examination, Ultrasonography and a non-stress test (NST). For eligible patients, and following an informed consent, group randomization will take place: GROUP 1: Expectant management (standard protocol). GROUP 2: Insertion of a balloon cervical catheter (study group). The randomization process will be as follows: A. The eligible patient will sign the informed consent prior to randomization. B. The patient will receive a subject number for the study (from 1 to 200) The study coordinator will open a sealed envelope with the patient's study number to reveal the patient's assigned study group.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Double balloon catheter for induction of labor

Arm Type

Experimental

Arm Description

Arm Title

Expectant management

Arm Type

No Intervention

Arm Description

Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.

Intervention Type

Device

Intervention Name(s)

Double Balloon catheter for induction of labor

Other Intervention Name(s)

Atad Ripener Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Vaginal birth after cesarean (VBAC) rates

Time Frame

5 days

Secondary Outcome Measure Information:

Title

PROM to delivery interval (time)

Time Frame

5 days

Title

intrapartum and post-partum infection rates

Time Frame

5 days

Title

Cesarean section rates

Time Frame

5 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Only patients who meet the following criteria will be approached. Singleton Pregnancy Previous single cesarean section At least 12 months have elapsed since the previous caesarean delivery Diagnosed with confirmed PROM at ≥ 34 weeks' gestation. Ruptured membranes have occurred ≤24 hours prior to inclusion in the study. Vertex presentation well applied to the cervix Found to have an unripe cervix in a speculum examination (Bishop score ≤6). Absence of significant and regular uterine contraction (<3/10Min). Willingness to comply with the protocol for the duration of the study. 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: Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery < 12 months). Regular uterine contractions (>3/10Min). Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion. Meconium stained amniotic fluid. Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000) Suspected placental abruption or a significant hemorrhage. Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gil Gutvirtz, MD

Phone

972509630022

Giltzik@gmail.com

Facility Information:

Facility Name

Soroka University Medical Center

City

Be'er Sheva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gil Gutvirtz, MD

Phone

972509630022

Giltzik@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Balloon Induction of Labor in PROM for TOLAC

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