Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
Healthy Volunteers
ID06506721

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-01-14

137

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two mechanical methods for inducing labor in women who have had a previous cesarean section. The study focuses on evaluating the Dilapan-S hygroscopic cervical dilator and the Cook double balloon catheter to better understand their effectiveness and patient satisfaction. This research aims to fill the current gap in data regarding the best approach for mechanical labor induction in this group, where such methods are considered off-label. The main goal is to measure the time from device placement to delivery, with other outcomes including cesarean delivery rates and patient satisfaction. The study involves two groups: one where labor is induced using the Cook double balloon device, which is inserted into the cervix and inflated with saline, remaining in place until labor begins or up to 12-24 hours before removal and possible further induction steps. The other group uses up to five Dilapan-S rods inserted after humidification, fixed with a vaginal compress, and left until labor starts or up to 12-24 hours before removal, followed by oxytocin and amniotomy if needed. If labor does not progress after additional oxytocin infusions, cesarean delivery is planned. Participants will be monitored closely during and after induction, with assessments including delivery timing, cesarean rates, neonatal outcomes within 2 hours, maternal infection rates within 96 hours, and patient satisfaction. The study includes women aged 18 to 60 with a previous cesarean and an indication for labor induction. Safety and effectiveness will be tracked throughout, with the total follow-up covering at least 72 to 96 hours after induction.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 60 years
  • Previous cesarean section (one only)
  • Indication for labor induction between 24 and 42 weeks of pregnancy
  • Modified Bishop score less than 6
  • Provided informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Up to 72 hours

Participants undergo labor induction using either the Cook double balloon device or hygroscopic cervix dilators (Dilapan-S). The device remains in place until it is spontaneously expelled or active labor begins. If not, the device is removed after 12 to 24 hours, followed by oxytocin administration and amniotomy as soon as feasible. If the cervix remains unfavorable, further oxytocin infusion cycles may occur before cesarean delivery is considered.

1 to 2 in-person visits during induction

Trial Site Locations

Total: 1 location

1

University Hospital of Obstetrics and Gynäkologie, Inselspital

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

A

Anda P Radan, PD Dr. med.

M

Mihaela M Fluri, Dr. med.univ.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

ACOG Committee Opinion No. 342: induction of labor for vaginal birth after cesarean delivery.

American College of Obstetricians and Gynecologists Committee on Obstetric Practice

https://pubmed.ncbi.nlm.nih.gov/16880321

Safe prevention of the primary cesarean delivery.

American College of Obstetricians and Gynecologists (College), Society for Maternal-Fetal Medicine, Aaron B Caughey...

https://pubmed.ncbi.nlm.nih.gov/24565430

Guidelines for vaginal birth after previous Caesarean birth.

Marie-Jocelyne Martel, Catherine Jane MacKinnon, Clinical Practice Obstetrics Committee, Society of Obstetricians and Gynaecologists of Canada

https://pubmed.ncbi.nlm.nih.gov/15943001

Safety and effectiveness of labour induction after caesarean section using balloon catheter or oxytocin.

Anda-Petronela Radan, Sofia Amylidi-Mohr, Beatrix Mosimann...

https://pubmed.ncbi.nlm.nih.gov/29120029