Management of Labor in Patients With Previous Cesarian Section

Hillel Yaffe Medical Center

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Previous Cesarian Section

Premature Rupture of Membranes (PROM)

Pregnancy

Treatments

Device: Double balloon cervical catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT02196103

0019-14-HYMC

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.