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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Fakultni Nemocnice Brno Brno Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
01.04.2026

Trial locations

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.

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 ID:
2026-525770-19-00
Protocol code:
OPTIMISO-2026
Trial Phase:
Therapeutic confirmatory (Phase III)

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