Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
NCT ID: NCT06794385
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2025-01-22
2025-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group undergoing labor induction with the dinoprostone vaginal delivery system
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction. The medication will be inserted into the posterior fornix of the vagina, with the active substance being released over a 24-hour period. Maternal and fetal health will be monitored during their stay on the ward. Upon the onset of contractions or any signs of fetal distress, patients will be transferred to the delivery unit. If labor does not commence and the cervix remains unfavorable after 24 hours, a new vaginal delivery system will be inserted for an additional 24 hours. If no progress is observed within 48 hours of induction, a mechanical method for labor induction or cesarean delivery will be employed. After delivery, women will complete a questionnaire to assess their satisfaction with the childbirth experience.
dinoprostone vaginal delivery system
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
Group undergoing labor induction with the 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 until adequate uterine contractions and a favorable cervical condition are achieved. A maximum of 8 doses will be administered on the first day. If labor does not commence and the cervix remains unfavorable, a second induction cycle will be initiated the following day. If no progress occurrs after 48 hours from the induction, participants will undergo cesarean delivery, or alternative mechanical induction method will be used. Following delivery, participants will complete a questionnaire to assess their satisfaction with the childbirth experience.
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
Interventions
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dinoprostone vaginal delivery system
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
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
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Viable fetus in cephalic presentation
* Bishop score ≤ 6
* Maximum parity of three
* Reactive CTG at admission without pathological findings
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Locations
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UMC Ljubljana
Ljubljana, , Slovenia
Countries
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Central Contacts
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Other Identifiers
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0120-403/2024-2711-3
Identifier Type: -
Identifier Source: org_study_id
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