Status:
UNKNOWN
Management of Labor in Patients With Previous Cesarian Section
Lead Sponsor:
Hillel Yaffe Medical Center
Conditions:
Pregnancy
Previous Cesarian Section
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
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 under...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02196103
Start Date
September 1 2014
End Date
September 1 2018
Last Update
July 21 2014
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