Actively Recruiting

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

Comparison of Cook Double Balloon and Dilapan-S Hygroscopic Cervical Dilators for Labor Induction After Previous Cesarean Section An Open Randomized Controlled Trial

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

137

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial investigates the use of two mechanical devices, the Dilapan-S and the Cook double balloon catheter, for inducing labor in women who have had a previous cesarean section. There is limited data comparing these two methods for this patient group, and both methods are currently used off-label. The main goal is to measure the time from device placement to delivery, with additional outcomes including cesarean delivery rates and patient satisfaction with the induction methods. The study involves two groups: one receiving the Cook double balloon catheter and the other receiving the Dilapan-S hygroscopic cervical dilators. Both devices are inserted transcervically and remain in place until spontaneous expulsion or the start of active labor, or for up to 12-24 hours. If labor does not start, the devices are removed and oxytocin is given along with amniotomy. If the cervix remains unfavorable after oxytocin treatment, cesarean delivery is performed. The Dilapan-S device may offer benefits such as better mobility and comfort during induction. Participants will be monitored for the induction-to-delivery interval and other outcomes over a 72-hour period. Assessments include cervical status, labor progress, and patient feedback on satisfaction. Safety is closely observed, and cesarean delivery is considered if induction fails or complications arise. The study includes women aged 18 to 60 with a prior cesarean and requires careful follow-up during the labor induction process.

CONDITIONS

Official 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 18 years or older with one previous cesarean section and labor induction indicated between 24 and 42 weeks of pregnancy
  • Modified Bishop score less than 6
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • More than one previous cesarean section
  • Premature rupture of membranes
  • Vaginal infection
  • Intrauterine fetal death
  • Twin pregnancy
  • Contraindication to labor induction or vaginal delivery
  • Vaginal bleeding
  • Planned simultaneous external prostaglandin administration
  • Placenta praevia, vasa praevia, or placenta accreta spectrum
  • Transverse fetal position
  • Prolapsed umbilical cord
  • Prior uterine surgeries other than one cesarean (e.g., hysterotomy, classic incision, myomectomy)
  • Pelvic structural abnormalities
  • Active genital herpes infection
  • Invasive cervical cancer
  • Abnormal fetal heart rate patterns
  • Breech presentation
  • Maternal heart disease
  • Polyhydramnios
  • Presenting part above pelvic inlet
  • Severe maternal hypertension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Hospital of Obstetrics and Gynäkologie, Inselspital

Bern, Switzerland, 3010

Actively Recruiting

Loading map...

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

Similar Trials

Intrathecal Chloroprocaine 1% Versus Ropivacaine 0.75% Durin...

Cesarean Section

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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