Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
Qualifiers
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
Disqualifiers
More than 1 CS
Premature rupture of membranes
Vaginal infection
Intrauterine fetal demise
Trial design
Treatments tested in this trial
- Double ballon device, Cook
- Hygroscopic cervix dilators, Dilapan-S
Treatment groups
137 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov