Balloon Induction of Labor in PROM for TOLAC

Not Applicable

• Conditions: Prelabor Rupture of Membranes; Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
• Interventions: Device: Double Balloon catheter for induction of labor

• Registration Number: NCT03399266
• Lead Sponsor: Soroka University Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-16
• Study Start: 2018-03-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-14
• Primary Completion: 2020-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double balloon catheter for induction of labor	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.

Primary Outcome Measures

Name	Time	Method
Vaginal birth after cesarean (VBAC) rates	5 days

Secondary Outcome Measures

Name	Time	Method
PROM to delivery interval (time)	5 days
intrapartum and post-partum infection rates	5 days
Cesarean section rates	5 days

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Be'er Sheva, Israel