Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Balloon + Oxytocin versus Oral Misoprostol to Induce labor in case of premature rupture of membranes (PROM) at term in nulliparous

This study is for pregnant women whose waters have broken, but labour hasn't started yet. This is called 'premature rupture of membranes at term'. We are comparing two common methods used to help start labour: using a small balloon placed in the womb, or a tablet called Misoprostol. Both methods aim to encourage the cervix to open so labour can begin. We want to see which method helps women give birth vaginally faster, ideally within 24 hours. We also want to understand how women feel about their experience with each method, looking at things like how long it took to give birth, any discomfort they felt, and their experience of contractions. The goal is to find the best and most comfortable way to help mums have their babies when their waters have broken.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

CHU Gabriel-Montpied

Enrolment target

520

Start

15 Sep 2022

pregnant women with premature rupture of membranes

What is this study about?

When your waters break, but labour doesn't start on its own, doctors often recommend helping to get things going. This is because there's a risk of infection for both mum and baby if there's too long a delay after the waters have broken. This study is exploring two common ways to start labour, known as 'induced labour' or 'induction'. One method involves using a small balloon that is gently placed just inside the womb. The balloon is then slowly inflated which helps to open up the cervix (the neck of the womb). The other method uses a tablet called Misoprostol, which is usually placed near the cervix and helps to soften and open it, to encourage contractions to start.

We want to find out which of these two methods helps women give birth vaginally most quickly, ideally within 24 hours of starting the induction process. We also want to understand women's experiences with each method. We'll be asking about how long it took from starting induction to holding their baby, any discomfort they felt during the process, and their experience of labour contractions. This will help us understand not just what works best medically, but also what feels best for mums.

Ultimately, this study aims to help doctors make even better decisions about how to safely and comfortably help women whose waters have broken to have their babies. By comparing these two widely used methods, we hope to improve the care that pregnant women receive in the UK.

Key takeaways

Compares balloon vs. Misoprostol for labour induction after waters break.
Aims to find the fastest and most comfortable method for first-time mums.
Explores how women feel about the induction process.
Participation involves receiving one of two standard induction methods.
Helps improve future care for pregnant women in the UK.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for pregnant women who are at full term (meaning their pregnancy has reached 37 weeks or more) and whose waters have broken, but their labour hasn't started naturally yet. This situation is called 'premature rupture of membranes' (PROM) at term.

You would need to be at least 18 years old to take part. The study is specifically for women who are having their first baby. If you've had a baby before, you wouldn't be able to join this particular study.

Generally, if you are a pregnant woman over 18, having your first baby, and your waters have broken but labour hasn't begun, you might be eligible to participate. Your medical team will check all your health details to make sure it's safe and suitable for you.

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 currently pregnant?
Have your waters broken, but labour hasn't started?
Are you at least 37 weeks pregnant?
Are you 18 years old or older?
Is this your first baby (meaning you've never given birth before)?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to either receive the balloon method or the Misoprostol tablet to help start your labour. This decision is made by chance, like flipping a coin. You will receive standard medical care during your labour and birth.

Researchers will keep a close eye on various aspects of your labour, such as how long it takes for labour to start, how long it takes until your baby is born, and how much medication you might need. They will also note any medical events during labour, like fever or heavy bleeding, and how your baby is doing after birth.

After your baby is born, and before you go home from the hospital (usually between the second day after delivery and when you're discharged), you'll be asked to complete a questionnaire. This questionnaire is designed to understand your experience of the induction process, focusing on the time it took, any discomfort, and your experience of contractions. The total duration of your participation would be from when you start induction until you leave the hospital with your baby.

Potential risks and benefits

Taking part in this study means you'll receive one of two common, established methods for inducing labour when your waters have broken. Potential benefits include contributing to medical knowledge that could improve care for future mums. While both methods are standard practice, like any medical procedure, there are potential risks such as infection, changes in labour pattern, or needing a caesarean section. The study will carefully monitor you and your baby throughout the process. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What does 'premature rupture of membranes at term' mean?

It means your waters have broken naturally, but your pregnancy has reached 37 weeks or more, and your labour hasn't started on its own yet.

What is 'induction of labour'?

It's when doctors use medicines or procedures to help start your labour if it hasn't begun naturally and it's safer for your baby to be born.

What's the difference between the balloon and the tablet for induction?

The balloon is a physical method to gently open your cervix. Misoprostol is a tablet that makes your cervix soften and open, and helps contractions start.

Will I get to choose which induction method I receive?

No, in this study, the method you receive will be decided by chance, like drawing lots, to ensure fairness and accurate comparison between the two methods.

How will my experience be measured?

We'll ask you to fill out a questionnaire after your baby is born, focusing on aspects like how long labour took, any discomfort, and how you felt about your contractions.