Recruiting NA Delivery, Obstetric

New treatment option for Delivery, Obstetric

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

ClinicalTrials.gov ID: NCT06506721

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 60, women only. Healthy volunteers may be eligible.

You may be able to join if

  • 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

You likely can't join if

  • More than 1 CS
  • Premature rupture of membranes
  • Vaginal infection
  • Intrauterine fetal demise
  • Twin pregnancy
  • Contraindication against labour induction or vaginal delivery
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Bern, Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.