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

January 10, 2025 updated by: Insel Gruppe AG, University Hospital Bern

Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The cesarean section (CS) rate is increasing worldwide, with previous CS being an important factor contributing to this trend. The investigators think that VBAC may be safe, provided a careful selection of the patients is performed. The individual birth management is particularly important if labour has to be induced, as in case of approximately 25% of women attempting VBAC. Counselling patients about labour induction can be challenging, as they should be offered not only a safe, but also an effective method. Labor induction can be achieved by using several approaches: administration of drugs, which induce uterine contractions, such as prostaglandins or oxytocin, performing an amniotomy, or using mechanical methods. In Switzerland and implicitly in the investigators' institution, PGE after CS are rarely employed in carefully selected cases. Oxytocin administration after performing amniotomy is considered to be a safe method, but may be less effective with an unfavorable BISHOP score (<6).

An possible alternative in case of unripe cervix is induction of labour by use of mechanical methods: balloon catheters and laminaria stents. The investigators currently use the double balloon catheter device (Cook Inc) for this purpose. This device is inserted transcervically and both ballons are inflated with sterile 0.9% saline solution. The catheter remains in place until spontaneously expelled or until start of active labour. If neither happens, it will be removed after 12 hours, followed by oxytocin administration and amniotomy.

Recently, an alternative method for mechanical induction is gaining increased attention: the use of hygroscopic cervical dilators. The method seems to be equally effective and safe as directly compared to a single device catheter in a low risk population of women without uterine scar. When used in patients with previous cesarean section, the rate of spontaneous labour seems to resemble existent data for induction with balloon catheter, this including the investigators' collective.

One of the advantages of Dilapan-S® could be the lack of vaginal protrusion and the fact that it does not have to be fixated under tension. Women seem to feel more mobile with Dilapan®, the perception of relaxation moments between contractions as well as sleep periods during the induction seem to be improved with Dilapan®.

Study Type

Interventional

Enrollment (Estimated)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital of Obstetrics and Gynäkologie, Inselspital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Surbek, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion criteria:

  • More than 1 CS
  • Premature rupture of membranes
  • Vaginal infection
  • Intrauterine fetal demise
  • Twin pregnancy
  • Contraindication against labour induction or vaginal delivery
  • Vaginal bleeding
  • Simultaneous external administration of prostaglandins planned
  • Placenta praevia, vasa praevia or placenta accreta spectrum
  • Transverse fetal orientation
  • Prolapsed umbilical cord
  • Prior hysterotomy, classic uterine incision, myomectomy or any other full thickness uterine incision (except C-section)
  • Pelvic structural anomaly
  • Active genital herpes infection
  • Invasive cervical cancer
  • Abnormal fetal heart rate pattern
  • Breech presentation
  • Maternal heart disease
  • Polyhydramnios
  • Presentic part above the pelvic inlet
  • Severe maternal hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double balloon device
In this group of patients, the labour will be induced using the Cook double balloon device
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.
Active Comparator: Hygroscopic cervix dilators
In this group of patients, the labour will be induced using the hygroscopic cervix dilators Dilapan-S
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction-to-delivery interval (IDI) after induction of labour (COOK catheter or Dilapan) in women with previous CS.
Time Frame: 72 hours
The time between placement of the device and delivery
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean delivery rate
Time Frame: 72 hours
How many women will get at the end a C-section after inducing the labour
72 hours
Neonatal outcomes
Time Frame: 2 hours
The cord arterial pH (< 7.10)
2 hours
Neonatal outcomes
Time Frame: 2 hours
5 minutes APGAR-Score (< 7)
2 hours
Neonatal outcomes
Time Frame: 2 hours
Transfer to the ICU
2 hours
Maternal infection rate
Time Frame: 96 hours
To asses the maternal infection status the investigators use the temperature (fever >38.0°), Leucocytosis (> 16.000 G/l), CRP (> 50)
96 hours
Patient satisfaction
Time Frame: 96 hours
All participant will receive a questionnaire after birth regarding the time from induction initiation until active phase of labour, covering questions such as convenience of the induction method (multiplicity of vaginal manipulation, comfort and pain experience)
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2023

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1650
  • 10000993 (Other Identifier: Swissmedic)
  • 2019-02112 (Other Identifier: Cantonal Ethics Committee of Bern)
  • CIV-21-12-038486 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cesarean Section

Clinical Trials on Double ballon device, Cook

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe