Management of Labor in Patients With Previous Cesarian Section

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

Interventions

  • Device: Double balloon cervical catheter

Arms, Groups and Cohorts

  • Experimental: Expectant management

Clinical Trial Outcome Measures

Primary Measures

  • vaginal delivery rate
    • Time Frame: 48 hours
    • 20% higher vaginal delivery rate

Secondary Measures

  • safety
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hillel Yaffe Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Asnat Walfisch, MD, Principal Investigator, Hillel Yaffe Medical Center
  • Overall Contact(s)
    • Asnat Walfisch, MD, 050-4492200

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