AuthorisedTherapeutic use (Phase IV)Interventional

Optimising the protocol of labour induction using misoprostol – randomised open-label clinical trial (OPTIMISO)

The OPTIMISO study is a research trial exploring the best way to use a medication called misoprostol (Angusta) to help start labour. This is often needed when it's safer for the baby or mother if labour begins sooner. The study is comparing two different methods of giving misoprostol to see if a lower total amount of the medicine can be used effectively. Researchers will be carefully observing how much misoprostol is needed, any side effects, and important health outcomes for both the mother and baby. The aim is to find ways to make labour induction as safe and successful as possible, potentially reducing the total dose of medication mothers receive. This is a Phase IV study, meaning the medicine is already approved for use, and this research helps us understand the best ways to use it in practice.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fakultni Nemocnice Brno

Enrolment target

200

Start

28 May 2026

Labour induction

What is this study about?

This research study, called OPTIMISO, is looking into the best way to help start labour when it doesn't begin naturally. This process is known as 'labour induction'. Sometimes, for the health of the mother or baby, doctors decide it's safer for labour to start earlier than it might on its own. One common way to do this is by using a medicine called misoprostol, which comes as a tablet called Angusta.

The main goal of this study is to compare two different ways of giving misoprostol to mothers. We want to see if we can use a smaller total amount of the medicine over the course of the induction process while still making sure labour starts successfully. By potentially reducing the total dose, we hope to make the experience safer and more comfortable for mothers.

Researchers will be keenly watching many different things. This includes understanding how many doses of misoprostol are needed, whether there are any unwanted side effects for the mother or baby, and how the labour progresses. They'll also check on the baby's health at birth and shortly after. The overall aim is to improve how we help mothers start labour, making it as safe and gentle as possible.

Key takeaways

The OPTIMISO study is researching better ways to start labour.
It's comparing different ways of giving a medicine called misoprostol (Angusta).
The main goal is to see if a lower total dose can be effective and safe.
Researchers will monitor mothers and babies closely for health outcomes and side effects.
This study aims to make labour induction safer and more comfortable for mothers.

Who may be eligible?

To be able to join this study, women must be at least 18 years old. There is no upper age limit, so women of any age over 18 can take part. The study is specifically for women who are pregnant and need to have their labour started, also known as labour induction.

This study is designed for women who are already considering or have been advised to have their labour induced by their doctors. It's important that participants are healthy enough to undergo labour induction and meet certain other health requirements that the study doctors will check.

If you are pregnant, over 18, and your doctor thinks you need to have your labour started, you might be suitable for this study. Your medical team will discuss all the details with you to see if it's a good fit.

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 18 years old or older?
Are you currently pregnant?
Has your doctor recommended that your labour needs to be started (induced)?
Are you able to provide consent (agreement) to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the medicine (misoprostol/Angusta) to help start your labour, just as you would if you weren't in the study. The main difference is that the way the medicine is given might be part of the study's comparison. The medical team will carefully monitor your progress throughout labour. They will collect information about how your labour starts, how long it takes, and how you and your baby are doing. This includes monitoring for any side effects and recording details about your delivery and your baby's health shortly after birth. There will be no extra visits or tests beyond what is normally part of good maternity care; the study simply collects more detailed information during your existing care. The total duration of your participation would be from when you start your labour induction until you are discharged from the hospital after giving birth.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to our understanding of the best and safest ways to induce labour, potentially improving care for future mothers. You would receive the standard care for labour induction, with very close monitoring. All medications used are already approved. Potential risks are generally similar to those associated with labour induction itself, such as the possibility of needing a caesarean section or experiencing certain side effects, which will be closely monitored by the medical team. 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
Czechia

Common questions

What is 'labour induction'?

Labour induction is when doctors use medicines or other methods to help start labour when it hasn't begun naturally, usually because it's safer for the mother or baby.

What is misoprostol (Angusta)?

Misoprostol (brand name Angusta) is a medicine given as a tablet that helps prepare the womb and cervix to start labour.

What is the study hoping to achieve?

The study aims to find the most effective and safest way to use misoprostol for labour induction, specifically looking at if a lower total dose can still be successful.

Will I get different care if I join the study?

You will receive the same high standard of care for labour induction, but the study will involve collecting more detailed information about your progress and the use of the medication.

Is this medicine new?

No, misoprostol (Angusta) is an approved medicine already used to induce labour. This study is about finding the best way to give it.