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