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

NCT06794385 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-01-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794385 on ClinicalTrials.gov