Actively Recruiting
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-01-14
137
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years or older with one previous cesarean section and labor induction indicated between 24 and 42 weeks of pregnancy
- Modified Bishop score less than 6
- Signed informed consent
You will not qualify if you...
- More than one previous cesarean section
- Premature rupture of membranes
- Vaginal infection
- Intrauterine fetal death
- Twin pregnancy
- Contraindication to labor induction or vaginal delivery
- Vaginal bleeding
- Planned simultaneous external prostaglandin administration
- Placenta praevia, vasa praevia, or placenta accreta spectrum
- Transverse fetal position
- Prolapsed umbilical cord
- Prior uterine surgeries other than one cesarean (e.g., hysterotomy, classic incision, myomectomy)
- Pelvic structural abnormalities
- Active genital herpes infection
- Invasive cervical cancer
- Abnormal fetal heart rate patterns
- Breech presentation
- Maternal heart disease
- Polyhydramnios
- Presenting part above pelvic inlet
- Severe maternal hypertension
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Obstetrics and Gynäkologie, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
A
Anda P Radan, PD Dr. med.
CONTACT
M
Mihaela M Fluri, Dr. med.univ.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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