RecruitingNAINTERVENTIONAL

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

This study, called OutCRIB, is investigating the best way for pregnant women to start labour when it needs a helping hand (also known as induction). Researchers want to compare starting labour at home using a special balloon with staying in hospital to start labour. They are particularly interested in women who are considered low-risk and are at full term. The main goal is to see if starting labour at home can make the process quicker and more comfortable. They will also look at how satisfied mothers are, any effects on babies, and the overall cost. If you're eligible, you might be asked to take part to help understand if starting induction at home is a good option for future parents.

At a glance

Status

Recruiting

Phase

Sponsor

Nantes University Hospital

Enrolment target

258

Start

30 Apr 2026

Estimated completion

15 Jan 2028

Pregnant Women

What is this study about?

When a woman is pregnant and her labour needs a little nudge to get started, doctors call this 'induction of labour'. Sometimes, a balloon can be used to help open the neck of the womb (cervix) to get things going. This study is trying to find out if it's better for women to have this balloon put in and then go home to wait for labour to start (outpatient care), or to stay in the hospital while waiting (inpatient care).

The main question the researchers want to answer is whether going home makes the whole process of induction and labour shorter, and if women are happier with this approach. They are very focused on the safety of both the mother and the baby. They’ll also be looking at things like how satisfied mothers are with their experience, any health matters for mum or baby, and how the different approaches affect hospital services and costs.

This study is for women who are at full term with one baby and need their labour induced. By comparing these two ways of starting labour, the hope is to find the safest, most comfortable, and most efficient method that could benefit many pregnant women in the future. Your involvement could help improve care for other families.

Key takeaways

This study compares starting labour at home versus in hospital using a balloon.
It's for low-risk pregnant women at full term who need their labour induced.
The aim is to find out if at-home induction is quicker, safer, and preferred by mothers.
Participation involves having a balloon inserted and then being randomly assigned to go home or stay in hospital.
Your involvement could help improve future care for pregnant women.
You can stop taking part at any time without affecting your care.

Who may be eligible?

To be part of this study, you need to be pregnant with one baby and be at least 37 weeks pregnant. You also need to be 18 years old or over and part of a UK social security scheme.

There are some specific health requirements: you shouldn't have any serious health problems yourself, and your baby shouldn't have any serious health issues. You'll also need a specific reason for needing your labour induced using a balloon, and your cervix shouldn't be too open yet.

Finally, for the 'going home' option to be suitable, you'll need to live within a 30-minute drive of the hospital and have someone at home who can help you after the balloon is inserted.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant with one baby?
Are you 37 weeks pregnant or more?
Are you 18 years old or older?
Do you live within a 30-minute drive of the hospital?
Do you have someone at home who can support you if you're in the 'home' group?
Are you generally healthy, with no serious underlying health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is for a doctor or midwife to check if you're suitable. If you are, and you agree, a small sensor will be placed on your tummy to monitor your baby's heartbeat. If everything looks fine, a midwife will carefully insert the balloon into your cervix. They'll then check your baby's heartbeat again to make sure you're both comfortable.

Next, you'll be randomly assigned to one of two groups: either you'll go home with the balloon in place (outpatient group), or you'll stay in a hospital room (inpatient group). Whether you're at home or in hospital, the balloon will typically stay in for up to 24 hours. If labour hasn't started on its own by then, you'll come back to the delivery room to have the balloon removed and other methods, like breaking your waters or giving you medication, will be used to help start your labour. There won't be many extra visits beyond your usual antenatal care, as the main comparison is simply where you wait for the induction to progress.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that if you're in the 'at-home' group, you might find the early stages of induction more comfortable in your own environment. Your experience could also help improve care for future pregnant women. As for risks, there's always a small risk of complications with any medical procedure, though this balloon method is commonly used. The researchers will be closely monitoring both mothers and babies for any issues in both groups. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

CHU de Nantes
Verified postcode
Nantes, France· Recruiting
CHD Vendée
Verified postcode
La Roche-sur-Yon, France· Recruiting

Common questions

What is 'induction of labour'?

It's when doctors help to start your labour if it doesn't begin naturally when expected or if there's a medical reason to do so.

What is a 'double balloon transcervical catheter'?

It's a small device, like a tube with two balloons, that is gently put into your cervix (the neck of your womb) to help it open and encourage labour to start.

What's the difference between outpatient and inpatient care in this study?

Outpatient means you go home after the balloon is inserted, while inpatient means you stay in the hospital while waiting.

Will I get to choose if I go home or stay in hospital?

No, you'll be randomly assigned to one of the groups, like flipping a coin, to make sure the comparison is fair.

What if I change my mind about taking part?

You can withdraw from the study at any point, and it won't affect the medical care you receive.

How to find out more

MARION GAUTIER

marion.gautier@chu-nantes.fr +33253526204 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.