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

Soroka University Medical Center1 site in 1 country200 target enrollmentMarch 1, 2018

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
Sponsor: Soroka University Medical Center
Enrollment: 200
Locations: 1
Primary Endpoint: Vaginal birth after cesarean (VBAC) rates
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 1, 2018

End Date

March 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Soroka University Medical Center

Responsible Party

Principal Investigator

Gil Gutvirtz MD

Ob/Gyn Resident

Soroka University Medical Center

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.

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.