Management of Labor in Patients With Previous Cesarian Section

Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Previous Cesarian Section; Premature Rupture of Membranes (PROM)
• Intervention / Treatment: Device: Double balloon cervical catheter

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expectant management	Device: Double balloon cervical catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaginal delivery rate	20% higher vaginal delivery rate	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety	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.	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction	maternal experience and satisfaction with the method of delivery that was applied	48 hours

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Asnat Walfisch, MD, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: PROM; Mechanical cervical ripening; TOLAC; Previous Cesarian section
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 0019-14-HYMC