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. 2017 Jun 9;2017(6):CD009792. doi: 10.1002/14651858.CD009792.pub3

NCT02196103.

Trial name or title Management of labour in patients with previous cesarean section
Methods 2‐arm randomised controlled trial, randomisation method unclear, open label
Participants Setting: Israel
Inclusion criteria: pregnant women, prelabour rupture of the membranes at > 34 weeks (ruptured membranes in the 24 h prior to inclusion in the study), unripe cervix. Singleton in cephalic position. 1 previous CS. No contractions
Exclusion criteria: any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation), regular uterine contractions (3‐5/10 min), diagnosis of uterine rupture was made over 24 h prior to study inclusion, evidence of chorioamnionitis (T 37.6 oC with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC ≥ 20,000), suspected placental abruption or presence of a significant haemorrhage, non‐reassuring fetal status (as determined by fetal heart rate monitoring and/or bio‐physical profile) necessitating immediate intervention
Interventions Experimental intervention: double‐balloon cervical catheter
Control/Comparison intervention: expectant management
Outcomes Vaginal delivery rate, safety (fetal heart rate, uterine haemorrhage, maternal haemodynamic changes, uterine atony), satisfaction (maternal experience and satisfaction)
Starting date This study is not yet open for participant recruitment
Contact information Asnat Walfisch MD, Hillel Yaffe Medical Center
Notes NCT02196103

CS: caesarean section
 WBC: white blood count