Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Recruiting now · Not applicable
Conditions studied: Delivery, Obstetric, Cesarean Section, Obstetric Delivery
In brief
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.
Key facts
- Study ID
- NCT06506721
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 137
- Starts
- 2023-12-29
- Expected to finish
- 2026-12-28
- Last updated by the study team
- 2025-01-14
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University Hospital of Obstetrics and Gynäkologie, Inselspital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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