NCT06506721 Comparison Between Two Medical Devices for Labor Induction After Previous C-section
| NCT ID | NCT06506721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Delivery, Obstetric |
| Study Type | INTERVENTIONAL |
| Enrollment | 137 participants |
| Start Date | 2023-12-29 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 137 participants in total. It began in 2023-12-29 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of the study ist to compare the Dilapan-S and the Cook Ballon device for the mechanical induction of labour in women with a previous C-section. There is currently lack of data regarding this comparison of the two methods for mechanical labour induction in this patient collective. Any method used for labour induction is therefore off-label. The primary outcome is the time between placement of the device and delivery. Ad secondary outcomes are among others the cesarean delivery rate and patient satisfaction with the induction method.
Eligibility 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
Contact & Investigator
Daniel Surbek, Prof. Dr.
PRINCIPAL INVESTIGATOR
Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06506721 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Delivery, Obstetric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506721 currently recruiting?
Yes, NCT06506721 is actively recruiting participants. Contact the research team at Anda-Petronela.Radan@insel.ch for enrollment information.
Where is the NCT06506721 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06506721 clinical trial?
NCT06506721 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Daniel Surbek, Prof. Dr. at Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern. The trial plans to enroll 137 participants.