Management of Labor in Patients With Previous Cesarian Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Pregnancy Previous Cesarian Section Premature Rupture of Membranes (PROM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expectant management

Group Type EXPERIMENTAL

Double balloon cervical catheter

Intervention Type DEVICE

Interventions

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Double balloon cervical catheter

Intervention Type DEVICE

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No