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

NCT06794385 | Not Yet Recruiting Phase 4

• 1 other identifier: 0120-403/2024-2711-3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induction of Labour

Keywords

misoprostol; induction of labour; dinoprostone

Outcome Measures

Primary Outcomes (1)

• Time from induction to delivery

  The time from the insertion of the vaginal delivery system or administration of the oral tablet to the time of delivery

  1 week from induction

Secondary Outcomes (16)

• Time from induction to spontaneos vaginal delivery

  1 week from induction

• Time from induction to onset of active labour

  1 week from induction

• Use of oxytocin and its dosage

  1 week from induction

• Use of analgesia during labour

  1 week from induction

• Type of delivery

  1 week from induction

Study Arms (2)

Group undergoing labor induction with the dinoprostone vaginal delivery system

ACTIVE COMPARATOR

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.

Drug: dinoprostone vaginal delivery system

Group undergoing labor induction with the low dose peroral misoprostol

ACTIVE COMPARATOR

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.

Drug: low dose peroral misoprostol

Interventions

dinoprostone vaginal delivery system DRUG

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 dinoprostone vaginal delivery system

low dose peroral misoprostol DRUG

Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours

Group undergoing labor induction with the low dose peroral misoprostol

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Central Study Contacts

POLONA PEČLIN

CONTACT

0038615226162; polona.peclin@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 27, 2025
• Study Start: January 22, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)