Balloon Induction of Labor in PROM for TOLAC (NCT03399266) | Clinical Trial Compass
UnknownNot Applicable
Balloon Induction of Labor in PROM for TOLAC
Israel200 participantsStarted 2018-03-01
Plain-language 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 cesarean) with PROM (pre labor rupture of membranes).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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)