Comparing two devices for inducing labor in women with a previous C-section
Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled Trial
NA · Insel Gruppe AG, University Hospital Bern · NCT06506721
This study is testing two devices to see which one helps women who had a previous C-section have a quicker and safer labor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 137 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06506721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a previous cesarean section and an indication for labor induction between 24-42 weeks of pregnancy.
Not a fit: Patients with multiple cesarean sections, certain pregnancy complications, or contraindications to labor induction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer and more effective options for labor induction in women with a history of cesarean delivery.
How similar studies have performed: While there is limited data on the direct comparison of these two devices, similar studies on mechanical induction methods have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Delivery, Obstetric, Cesarean Section, Obstetric Delivery, Trial of Labour