Status:
UNKNOWN
Balloon Induction of Labor in PROM for TOLAC
Lead Sponsor:
Soroka University Medical Center
Conditions:
Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
Prelabor Rupture of Membranes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesa...
Eligibility Criteria
Inclusion
- Only patients who meet the following criteria will be approached.
- Singleton Pregnancy
- Previous single cesarean section
- At least 12 months have elapsed since the previous caesarean delivery
- Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
- Ruptured membranes have occurred ≤24 hours prior to inclusion in the study.
- Vertex presentation well applied to the cervix
- Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
- Absence of significant and regular uterine contraction (\<3/10Min).
- Willingness to comply with the protocol for the duration of the study.
- Have signed an informed consent (including a TOLAC consent form).
Exclusion
- Patients having any of the following conditions will be excluded from the study:
- Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery \< 12 months).
- Regular uterine contractions (\>3/10Min).
- Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion.
- Meconium stained amniotic fluid.
- Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
- Suspected placental abruption or 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 :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03399266
Start Date
March 1 2018
End Date
March 1 2021
Last Update
November 14 2018
Active Locations (1)
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1
Soroka University Medical Center
Beersheba, Israel