Comparing two devices for inducing labor in women with a previous C-section

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of two mechanical devices, the Dilapan-S and the Cook Balloon, for inducing labor in women who have previously undergone a cesarean section. The primary focus is on the time from device placement to delivery, while secondary outcomes include the rate of cesarean deliveries and patient satisfaction. The study addresses a gap in data regarding labor induction methods for this specific patient group, as current practices often involve off-label use of these devices. Participants will be carefully selected based on their medical history and current pregnancy status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All women \>= 18years old with a previous CS and an indication of labour induction, between 24-42 weeks of pregnancy.
* Modified Bishop-Score \< 6
* Informed consent

Exclusion criteria:

* More than 1 CS
* Premature rupture of membranes
* Vaginal infection
* Intrauterine fetal demise
* Twin pregnancy
* Contraindication against labour induction or vaginal delivery
* Vaginal bleeding
* Simultaneous external administration of prostaglandins planned
* Placenta praevia, vasa praevia or placenta accreta spectrum
* Transverse fetal orientation
* Prolapsed umbilical cord
* Prior hysterotomy, classic uterine incision, myomectomy or any other full thickness uterine incision (except C-section)
* Pelvic structural anomaly
* Active genital herpes infection
* Invasive cervical cancer
* Abnormal fetal heart rate pattern
* Breech presentation
* Maternal heart disease
* Polyhydramnios
* Presentic part above the pelvic inlet
* Severe maternal hypertension

Where it's running

• University Hospital of Obstetrics and Gynäkologie, Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Daniel Surbek, Prof. Dr. — Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern
• Study coordinator: Anda P Radan, PD Dr. med.
• Email: Anda-Petronela.Radan@insel.ch
• Phone: +41/0316321010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.