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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Brno

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2026-05-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Fakultní nemocnice Brno

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective of the study is to demonstrate that the concurrent administration of oral misoprostol and osmotic dilators reduces the total misoprostol dose compared with sequential administration for the induction of labour in women with an unprepared cervix.

Secondary objectives 4

1. To describe the exposure and safety in both arms
2. To compare the impact on perinatal outcomes in both arms
3. To compare the time aspects of the labour and the hospital stay in both arms
4. To compare the labour induction success

Conditions and MedDRA coding

Labour induction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Maternal age ≥ 18 years
2. Planned labour induction at gestational age 38+0 to 41+6 established by the attending gynaecologist during pre-labour check-in visit to the maternity hospital
3. Cervix (Bishop) score <6
4. Singleton pregnancy
5. Fetus alive
6. Cephalic presentation of the fetus
7. Physiological results of the last cardiotocography (CTG)
8. Signed informed consent

Exclusion criteria 13

1. Premature rupture of membranes
2. Clinical or laboratory symptoms of chorioamnionitis
3. Estimated fetal weight (EFW) <10th percentile or >95th percentile
4. Symptoms of intrauterine fetal distress on ultrasound or CTG examination
5. Congenital anomaly of the fetus
6. Uterine scar
7. Clinically manifest genital infection of the mother
8. Hepatitis B, hepatitis C, or HIV infection of the mother
9. Placenta praevia or unexplained vaginal bleeding
10. Other contraindication of vaginal delivery (at the discretion of the investigator)
11. Hypersensitivity to misoprostol or any excipient
12. Known renal impairment with eGFR <15ml/min/1.73m2
13. Other contraindication of misoprostol use (at the discretion of the investigator)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Reduction of total misoprostol dose in the concurrent arm vs. sequential arm

Secondary endpoints 7

1. Number of misoprostol doses
2. Incidence of adverse events related to either misoprostol or osmotic dilator
3. Maternal outcomes (Incidence of uterine tachysystole, uterine rupture, perineal trauma grade III and IV, blood loss ≥1000 mL, infection complications (chorioamnionitis, endometritis), maternal mortality)
4. Labour outcomes (Proportion of deliveries completed vaginally, vaginal extractions (VEX, forceps), CS, CS due to acute fetal hypoxia, CS due to failed induction of labour, manual lysis of the placenta, oxytocin i.v. use during labour, epidural analgesia use)
5. Fetal/Neonatal outcomes (perinatal mortality, Apgar score in the 1st, 5th and 10th minute after birth, birth weight, pH and base excess (BE) from the umbilical artery, incidence of infectious complications (sepsis, fever, infection proved by microbiological examination, clinical status requiring systemic antibiotics), neonatal seizures during 24 hours after birth, proportion of neonates admitted to the NICU during the first 24 hours after birth, neonatal mortality)
6. Duration of labour induction (time from induction start to the onset of the first stage of labour), first stage of labour, second stage of labour, time from induction start to the birth of the child, time from admission to discharge of the participant
7. Rate of successful induction in the first induction attempt, proportion of patients in need of induction retrial, rate of successful induction in the second induction attempt, rate of failed induction of labour

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Brno

Sponsor organisation

Fakultni Nemocnice Brno

Address

Obilni Trh 526/11, Veveri Veveri

City

Brno-Stred

Postcode

602 00

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Brno

Contact name

Lukáš Hruban

Public contact point

Organisation

Fakultni Nemocnice Brno

Contact name

Lukáš Hruban

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications