Status:
RECRUITING
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Delivery, Obstetric
Cesarean Section
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 ...
Detailed Description
The cesarean section (CS) rate is increasing worldwide, with previous CS being an important factor contributing to this trend. The investigators think that VBAC may be safe, provided a careful selecti...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2026
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT06506721
Start Date
December 29 2023
End Date
December 28 2026
Last Update
January 14 2025
Active Locations (1)
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1
University Hospital of Obstetrics and Gynäkologie, Inselspital
Bern, Switzerland, 3010