Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Sponsor: Insel Gruppe AG, University Hospital Bern
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.
Official title: Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
137
Start Date
2023-12-29
Completion Date
2026-12-28
Last Updated
2025-01-14
Healthy Volunteers
Yes
Interventions
Double ballon device, Cook
Cook double balloon will be introduced transcervically. The double balloon will be inflated with sterile 0-9% saline solution (maximum 80 ml in each balloon of the double device), then the catheter will be fixed with a tape at the women's thigh without traction. The catheter will remain in place until spontaneously expelled or start of active labour. If neither happens, the device will be removed after 12-24 hours and oxytocin will be administered and amniotomy as soon as feasible. If the cervix remains unfavorable after two cycles of 6 hours of oxytocin infusion, the induction will be classified as unsuccessful and C-section will be performed.
Hygroscopic cervix dilators, Dilapan-S
A maximum number of 5 hygroscopic cervical dilator rods will be inserted transcervically, after humidification with sterile 0.9% saline solution. They will be fixed in this position by inserting a humidified compress into the vagina. They will remain in place until spontaneously expelled or until start of active labour. In neither happens, the devices will be removed after 12-24 hours and oxytocin will be administered and amniotomy as soon as feasible. If the cervix remains unfavorable after two cycles of 6 hours of oxytocin infusion, the induction will be classified as unsuccessful and C-section will be performed.
Locations (1)
University Hospital of Obstetrics and Gynäkologie, Inselspital
Bern, Switzerland