Management of Labor in Patients With Previous Cesarian Section

Phase 2

• Conditions: Pregnancy; Premature Rupture of Membranes (PROM); Previous Cesarian Section
• Interventions: Device: Double balloon cervical catheter

• Registration Number: NCT02196103
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-17
• Last Update Submitted: 2014-07-17
• Study First Posted: 2014-07-21
• Last Update Posted: 2014-07-21
• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2018-09

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosed to be pregnant with PROM at >34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
• Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.
• Found to have an unripe cervix in a speculum examination.
• Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)
• Previous on cesarian section.
• Willingness to comply with the protocol for the duration of the study.
• Have signed an informed consent.

Exclusion Criteria

Patients having any of the following conditions:

• Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).
• Regular uterine contractions (3-5/10 min).
• Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.
• Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC>/=20,000)
• Suspected placental abruption or presence of a significant hemorrhage.
• 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Expectant management	Double balloon cervical catheter	-

Primary Outcome Measures

Name	Time	Method
vaginal delivery rate	48 hours	20% higher vaginal delivery rate

Secondary Outcome Measures

Name	Time	Method
safety	48 hours	safety of the double balloon device in women with one previous cesarian section and PROM at \>/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony.