Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Oral Misoprostol Combined with Osmotic Dilators for Labour Induction in Women with an Unprepared Cervix

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on women who need labour induction, a process used when a pregnancy has reached term but labor has not started on its own. The medication being tested is a low‑dose oral tablet called Angusta 25 µg, which contains the active ingredient misoprostol. In addition, small devices known as osmotic dilators are used; they gently expand the cervix by absorbing fluid, helping it become ready for labor.

The purpose of the study is to determine whether giving the tablet and the dilators at the same time reduces the total amount of misoprostol needed compared with giving them one after the other. Women will be randomly assigned to either a concurrent group, where both treatments start together, or a sequential group, where the dilators are placed first and the tablet is added later. The trial is open‑label, meaning both the participants and the health‑care team know which schedule is being used.

During the study, participants will be monitored for the number of tablet doses required, any side effects such as strong uterine contractions (called uterine tachysystole) or infection, and the progress of labor, including how often a vaginal delivery is achieved and whether any surgical delivery is needed. Information about the newborn’s health, such as birth weight and early breathing score, will also be recorded. The study follows the participants from the start of induction until discharge from the hospital after birth.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After signing the consent form, basic health information is recorded, including medical history and current pregnancy status.

    A physical examination and any required laboratory tests are performed to confirm eligibility for the trial.

  2. Step 2

    Randomisation

    The participant is assigned by the study system to one of two groups: the concurrent arm or the sequential arm.

    The assignment determines the order in which the study medications will be given.

  3. Step 3

    Administration of oral misoprostol

    The participant receives misoprostol tablets for oral use.

    Each tablet contains 200 µg of the active substance.

    The tablets are taken according to the schedule defined by the trial protocol, which may involve one or more doses until labour begins or the protocol specifies a stop point.

  4. Step 4

    Use of osmotic dilator (if assigned to concurrent arm)

    An osmotic dilator, a device that gently expands the cervix, is placed in the cervical canal.

    The dilator remains in place for the time period specified by the protocol while the oral misoprostol is administered.

  5. Step 5

    Monitoring during induction

    Regular checks are performed to observe uterine activity, fetal heart rate, and any signs of discomfort or adverse effects.

    The number of misoprostol doses given and any side effects are recorded.

  6. Step 6

    Labour progression

    Once the cervix is sufficiently softened, labour is allowed to progress naturally.

    Additional medical support, such as intravenous oxytocin or epidural analgesia, may be provided according to standard obstetric practice, but these are not part of the study medication.

  7. Step 7

    Delivery and immediate postpartum care

    The birth is attended by the obstetric team, and the mode of delivery (vaginal, assisted, or caesarean) is recorded.

    Maternal and newborn outcomes, including blood loss, infection signs, and newborn vital signs, are documented.

  8. Step 8

    Post‑delivery follow‑up until discharge

    The participant remains in the hospital for observation.

    Final assessments are made regarding any adverse events, total amount of misoprostol taken, and overall success of the induction.

    The participant is discharged when medically appropriate, and the study data collection is completed.

Who can join the trial?

8 criteria

  • You must be at least 18 years old.
  • Your doctor must plan to start labour when you are between 38 weeks and 41 weeks + 6 days of pregnancy.
  • Your cervix score (called the Bishop score) must be less than 6, meaning the cervix is not yet ready for labour.
  • You must be carrying a single baby (singleton pregnancy), not twins or more.
  • The baby must be alive.
  • The baby must be positioned head‑first (cephalic presentation).
  • The most recent heart‑rate monitoring test (cardiotocography or CTG) must show normal, physiological results.
  • You must sign an informed consent form agreeing to join the study.

Who cannot join the trial?

13 criteria

  • Premature rupture of membranes – the water breaking before labor starts.
  • Other reasons that make vaginal birth unsafe – any condition the doctor thinks makes a vaginal delivery risky.
  • Allergy (hypersensitivity) to misoprostol or any ingredient in the medication – a reaction that could cause rash, swelling, or breathing problems.
  • Severe kidney problems – kidney function measured as eGFR less than 15 ml/min/1.73 m², meaning the kidneys are not working well.
  • Other reasons that make misoprostol unsafe – any condition the doctor decides is a problem for using this drug.
  • Signs of infection in the uterus (chorioamnionitis) – fever, abdominal pain, or lab test results showing infection.
  • Very small or very large estimated fetal weight – baby weight below the 10th percentile or above the 95th percentile for its age.
  • Signs that the baby may be in distress – abnormal findings on ultrasound or heart‑rate monitoring (CTG) that suggest the baby is not doing well.
  • Major birth defect (congenital anomaly) in the baby – a serious structural problem present at birth.
  • Uterine scar – a previous C‑section or other surgery that left a scar on the uterus.
  • Active genital infection in the mother – an infection of the vagina or cervix that is currently causing symptoms.
  • Infection with hepatitis B, hepatitis C, or HIV – viruses that affect the liver (hepatitis) or immune system (HIV).
  • Placenta covering the opening of the uterus (placenta praevia) or unexplained vaginal bleeding – the placenta is in a position that can cause dangerous bleeding.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Misoprostol tablets are small pills taken by mouth that help start labor. In this study, the tablets are used to make the uterus contract so that a woman’s cervix can open and labor can begin. The researchers are testing whether giving these tablets together with another method can lower the amount of misoprostol needed to achieve a successful induction. Osmotic dilators are thin, soft devices that are placed in the cervix before labor induction. They absorb fluid and gently swell, which helps the cervix soften and open. In the trial, these dilators are used at the same time as the oral misoprostol tablets to see if this combined approach reduces the total amount of misoprostol required for a safe and effective induction of labor.

What is already known about the treatment

Misoprostol - Misoprostol is taken orally as a tablet, typically 25 µg per dose. It is an approved drug used worldwide for medical termination of pregnancy, gastric ulcer prevention, and induction of labour. It works by binding to prostaglandin receptors in the uterus, causing the muscles to contract and the cervix to soften. It belongs to the prostaglandin analog class.

Investigated diseases

Labour induction - Labour induction is the planned start of uterine contractions to begin childbirth when labour has not started on its own. It begins with the softening and thinning of the cervix, followed by the appearance of regular contractions. As contractions become stronger, the cervix continues to open and thin, allowing the baby to move down the birth canal. The process moves through the first stage of labour, where the cervix dilates, and then the second stage, where the baby is delivered. Throughout induction, the body follows the same sequence of changes that occur in natural labour.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525770-19-00Protocol codeOPTIMISO-2026Estimated enrolment200 patientsSponsorFakultni Nemocnice Brno

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).