Comparison Between Two Medical Devices for Labor Induction After Previous C-section

NARecruitingINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

December 29, 2023

Primary Completion Date

December 28, 2026

Study Completion Date

December 28, 2026

Conditions
Delivery, ObstetricCesarean SectionObstetric Delivery
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (1)

3010

RECRUITING

University Hospital of Obstetrics and Gynäkologie, Inselspital, Bern

All Listed Sponsors
lead

Insel Gruppe AG, University Hospital Bern

OTHER