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Optimising the protocol of labour induction using misoprostol – randomised open-label clinical trial (OPTIMISO)
EU CTIS ID: 2026-525770-19-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Maternal age ≥ 18 years
- 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
- Cervix (Bishop) score <6
- Singleton pregnancy
- Fetus alive
- Cephalic presentation of the fetus
You likely can't join if
- Premature rupture of membranes
- Other contraindication of vaginal delivery (at the discretion of the investigator)
- Hypersensitivity to misoprostol or any excipient
- Known renal impairment with eGFR <15ml/min/1.73m2
- Other contraindication of misoprostol use (at the discretion of the investigator)
- Clinical or laboratory symptoms of chorioamnionitis
See the full eligibility criteria
- Maternal age ≥ 18 years
- 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
- Cervix (Bishop) score <6
- Singleton pregnancy
- Fetus alive
- Cephalic presentation of the fetus
- Physiological results of the last cardiotocography (CTG)
- Signed informed consent
- Premature rupture of membranes
- Other contraindication of vaginal delivery (at the discretion of the investigator)
- Hypersensitivity to misoprostol or any excipient
- Known renal impairment with eGFR <15ml/min/1.73m2
- Other contraindication of misoprostol use (at the discretion of the investigator)
- Clinical or laboratory symptoms of chorioamnionitis
- Estimated fetal weight (EFW) <10th percentile or >95th percentile
- Symptoms of intrauterine fetal distress on ultrasound or CTG examination
- Congenital anomaly of the fetus
- Uterine scar
- Clinically manifest genital infection of the mother
- Hepatitis B, hepatitis C, or HIV infection of the mother
- Placenta praevia or unexplained vaginal bleeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.