RecruitingPHASE2INTERVENTIONAL

Mifepristone Outpatient Labour Induction

This study is investigating a new approach to help start labour (induction of labour) for pregnant women. Currently, many women need to go into hospital for several days for this, which can be a long and sometimes uncomfortable experience. We are exploring if a tablet called Mifepristone, which you might take before going to the hospital, could make this process better. The aim is to see if taking Mifepristone is effective and safe, potentially reducing the time women spend in hospital before giving birth. This could be particularly helpful in situations like the COVID-19 pandemic, where reducing hospital stays is important. The study compares Mifepristone with a dummy pill (placebo) to understand its benefits.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Chelsea and Westminster NHS Foundation Trust

Enrolment target

400

Start

25 Aug 2023

Estimated completion

31 Dec 2026

Labor, Induced

What is this study about?

For many women, doctors recommend starting labour artificially, a process called induction of labour. This can happen for various health reasons, and it's becoming more common, affecting about a third of all pregnancies. Often, this means spending a few days in the hospital before labour truly begins, using methods that can be slow and sometimes lead to a less positive birth experience. These methods can also be quite costly for the health service and aren't always popular with mothers.

At the moment, there aren't many good options for starting labour that can be done at home safely and effectively. The recent COVID-19 pandemic highlighted the need to reduce time spent in hospitals, especially for pregnant women who might be at higher risk. This study aims to find a better way.

We are looking into a medication called Mifepristone. The main idea is to see if taking this tablet could help ripen the cervix (the neck of the womb) at home before you go to the hospital. If it works well and is safe, it could mean less time in the hospital before labour starts, making the whole induction process smoother and more comfortable. This could also help reduce healthcare costs.

Key takeaways

Exploring a new way to start labour (induction) using a tablet.
Aims to reduce hospital stay before labour begins.
Compares Mifepristone tablet with a dummy tablet (placebo).
Focuses on safety and effectiveness for pregnant women.
Could make induction of labour a more positive experience.

Who may be eligible?

This study is looking for pregnant women who are between 36 weeks and 5 days and 41 weeks and 5 days pregnant. You need to be 18 years old or older and carrying one baby. Your cervix (the neck of your womb) would also need to be 'unfavourable', which means it's not quite ready for labour to start on its own, based on a doctor's check-up. You should also be able to understand the study information and be happy to sign a consent form to take part.

However, there are some reasons why you wouldn't be able to join. For example, if your baby is not head-down (breech), or if you're already in early labour. You also couldn't take part if there's a medical reason why a vaginal birth isn't recommended for you, such as certain placenta problems or if your baby is lying sideways. If your baby isn't growing well or has certain heart tracing concerns, or if you've had recent heavy bleeding, you wouldn't be suitable.

Other reasons that might stop you from joining include certain health conditions like active sexually transmitted infections, bleeding problems, or if you're taking particular medications like blood thinners or steroids. If you've had previous womb operations like a C-section or if you have specific kidney, liver, or adrenal gland issues, or very severe asthma, you wouldn't be able to join. Also, if you're allergic to Mifepristone or have recently taken another study drug that might interact with it.

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 between 36 and 41 weeks pregnant?
Are you carrying one baby, not twins or more?
Are you 18 years old or older?
Has your doctor said your cervix is not quite ready for labour?
Are you able to speak English and understand study information?
Have you *not* had a C-section or other womb surgery before?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two groups: one group will receive the Mifepristone tablet, and the other will receive a dummy tablet (placebo). Both groups will also receive the usual care for induction of labour. You won't know whether you've received the Mifepristone or the dummy tablet, and neither will your doctors.

Once you've taken the tablet, you will then be assessed in the hospital two days later. The study team will check on you during this time and after your baby is born to see how you and your baby are doing. This includes monitoring your progress, the effectiveness of the treatment, and any side effects. The total duration of your involvement will cover the period until two days after the treatment is completed and you're discharged from the immediate study follow-up.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a potentially shorter time in the hospital before labour begins or a more comfortable induction process. However, there's always a possibility that Mifepristone might not work as expected or might cause side effects. Like any medication, there are potential risks, though we will be carefully monitoring participants. You will be fully informed about all known potential risks before you decide to join. It is very important to remember that participating in this study is completely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Chelsea and Westminster Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'induction of labour'?

It's when doctors use medicines or other methods to help start labour artificially if it hasn't begun on its own when expected or needed.

What is Mifepristone?

It's a tablet that we are testing to see if it can help prepare your body for labour, making the induction process smoother.

Will I know if I'm getting the real tablet or a dummy one?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which tablet you've received.

Why is it called a 'Phase 2' trial?

This means it's an early stage of testing to see if the treatment is safe and effective in a small group of people, before larger studies are done.

What does 'unfavourable cervix' mean?

It means the neck of your womb isn't yet softened or open enough for labour to start easily, as assessed by your doctor.

How to find out more

Tess Cheetham

tess.cheetham@nhs.net +442033156825 Official trial record

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