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Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB (OutCRIB)

Join a study on labor induction with a double balloon catheter.

Recruiting
Female
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

Study Summary: This study is for pregnant women who need help starting labor, called induction. Researchers want to see if there's a difference in the time it takes to start labor for women who stay in the hospital compared to those who go home. A special tool called a "double balloon catheter" will be used to help start labor.

  • The study lasts about one month and involves a few hospital visits for checks.
  • Participants must be at least 18 years old, have a single baby, and be at least 37 weeks pregnant.
  • Women with certain health problems or previous uterine surgeries cannot join.

If you join, you'll have your baby's heart rate checked, and if it's safe, the balloon will be placed to help with labor. If labor doesn't start within 24 hours, further steps will be taken in the hospital. You will be randomly assigned to either stay in the hospital or go home after the balloon is placed.

This study does not involve any payment, but it will help doctors learn more about labor induction. It's important to have a family member with you if you go home.

Study details
    Pregnant Women

25 March 2026

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Step 1

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Informed consent
Introduction
You are being asked to participate in a research study. Before you decide to participate in this study, it is important that you understand why the research is being done and what it will involve. This form is designed to give you the information about the study so you can decide whether to be in the study or not. Please take the time to read the following information carefully. You should ask the researcher if there is anything that is not clear or if you need more information.
Study Participation
If you agree to participate in this study, you will be asked to:
  • Attend screening visit to determine eligibility
  • Attend 6–8 clinic visits over approximately 12 weeks
  • Provide blood samples at designated visits
  • Complete questionnaires about your symptoms and quality of life
  • Take study medication or placebo as directed
  • Report any side effects or health changes to the study team

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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