Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dinoprostone vaginal delivery system, low dose peroral misoprostol.
- Who it may be relevant to
- Registry conditions: Induction of Labour. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The objective of this interventional study is to compare the effectiveness, safety, and patient satisfaction associated with two commonly used methods of labor induction: low-dose oral misoprostol and the vaginal delivery system with dinoprostone. The study aims to identify the most suitable induction method for specific subgroups of patients based on parity, body mass index (BMI), age, and cervical ripeness, as well as assess patient preferences for these induction methods.
Interventions
- Drug dinoprostone vaginal delivery system
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction. - Drug low dose peroral misoprostol
Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours
Primary outcome measures
- Time from induction to delivery [Time frame: 1 week from induction]
Secondary outcome measures (12)
- Time from induction to spontaneos vaginal delivery [Time frame: 1 week from induction]
- Time from induction to onset of active labour [Time frame: 1 week from induction]
- Use of oxytocin and its dosage [Time frame: 1 week from induction]
- Use of analgesia during labour [Time frame: 1 week from induction]
- Type of delivery [Time frame: 1 week from induction]
- Hyperstimulation with nonreassuring fetal heart rate tracing [Time frame: 1 week from induction]
- Duration of labour [Time frame: 1 week from induction]
- Postpartum hemorrhage above 1000 mL [Time frame: 1 week from induction]
- Number of participants with third degree tear of perineum during labour [Time frame: 1 week from induction]
- Number of participants with fourth degree tear of perineum during labour [Time frame: 1 week from induction]
- Side effects of misoprostol and dinoprostone [Time frame: 1 week from induction]
- Number of newborns wtih 5-minute APGAR score of less than 7 [Time frame: 1 week from induction]
Eligibility criteria
Inclusion criteria
- Gestational age between 37 0/7 and 42 0/7 weeks
- Singleton pregnancy
- Viable fetus in cephalic presentation
- Bishop score ≤ 6
- Maximum parity of three
- Reactive CTG at admission without pathological findings
Exclusion criteria
- Age < 18 years
- Gestational age < 37 0/7 weeks
- Active labor
- Spontaneous rupture of membranes
- Non-reassuring CTG findings
- Suspected infection (e.g., fever > 38°C, chorioamnionitis, or unexplained systemic infection)
- Contraindications to vaginal delivery or prostaglandin use
- Previous cesarean delivery or uterine surgery involving entry into the uterine cavity
- Significant fetal abnormalities
- Severe fetal growth restriction with an estimated fetal weight below the 3rd percentile
- Non-Slovenian-speaking participants
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- UMC Ljubljana — Ljubljana
Identifiers
NCT: NCT06794385 · 0120-403/2024-2711-3