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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different medical devices, the Dilapan-S and the Cook Balloon, to help induce labor in women who have had a previous cesarean section (C-section). Inducing labor means starting labor artificially when it doesn’t start on its own, which can be necessary for various medical reasons. The study aims to find out which device is more effective by measuring how long it takes from when the device is placed until the baby is delivered. Additionally, the researchers will look at how often women need another C-section and how satisfied they are with the induction process.

To participate in this study, women must be at least 18 years old, have had one previous C-section, and be between 24 to 42 weeks pregnant with a low Bishop Score (a score that helps assess how ready the body is for labor). Some women may not be eligible if they have certain conditions like multiple C-sections, infections, or specific pregnancy complications. If you join the trial, you’ll receive one of the two devices to help with labor induction, and your progress and experiences will be closely monitored throughout the process. This study is important because it aims to provide better information on how to safely induce labor in women with a history of C-sections.

Gender

FEMALE

Eligibility criteria

• 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