MedTrace Logo

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

NCT06506721 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2025-01-14

No results posted yet for this study

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.

Conditions

  • Delivery, Obstetric
  • Cesarean Section
  • Obstetric 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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Daniel Surbek, Prof. Dr. · Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-29
Primary Completion
2026-12-28
Completion
2026-12-28

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506721 on ClinicalTrials.gov