Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction

University Medical Centre Ljubljana

Status and phase: Not yet enrolling; Phase 4

Conditions: Induction of Labour

Treatments: Drug: dinoprostone vaginal delivery system; Drug: low dose peroral misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT06794385

0120-403/2024-2711-3

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group undergoing labor induction with the dinoprostone vaginal delivery system

Active Comparator group

Description:

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.

Treatment:

Drug: dinoprostone vaginal delivery system

Group undergoing labor induction with the low dose peroral misoprostol

Active Comparator group

Description:

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.

Treatment:

Drug: low dose peroral misoprostol