Management of Labor in Patients With Previous Cesarian Section

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pregnancy, Previous Cesarian Section, Premature Rupture of Membranes (PROM)

Intervention / Treatment
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* Device: Double balloon cervical catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expectant management<br> | Device: Double balloon cervical catheter<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TOLAC, PROM, Previous Cesarian section, Mechanical cervical ripening