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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Induction of Labour
• Intervention / Treatment: Drug: dinoprostone vaginal delivery system; Drug: low dose peroral misoprostol

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: POLONA PEČLIN; Phone Number: 0038615226162; Email: polona.peclin@kclj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UMC Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: dinoprostone vaginal delivery system; Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from induction to spontaneos vaginal delivery	The time from the insertion of the vaginal delivery system or administration of the oral tablet to the time of spontaneous vaginal delivery	1 week from induction
Time from induction to onset of active labour	The investigators will measure the time from the insertion of the vaginal delivery system or administration of the oral tablet to the onset of active labor, defined as the occurrence of strong contractions every 5 minutes.	1 week from induction
Use of oxytocin and its dosage	The investigators will compare the need for oxytocin administration and its dosage, measured in international units (IU).	1 week from induction
Use of analgesia during labour	The need for epidural analgesia, remifentanil, N₂O, no analgesia.	1 week from induction
Type of delivery	Vaginal birth, Caesarean birth, Vacuum extraction	1 week from induction
Hyperstimulation with nonreassuring fetal heart rate tracing	Rate of uterine hyperstimulation- exaggerated uterine response consisting of uterine hypertonus, a single uterine contraction lasting two or more minutes or uterine tachysystole with a least 12 contractions in 20 minutes, with a simultaneous nonreassuring fetal heart rate tracing as defined by the 2015 FIGO (The international federation of gynaecology and obstetrics) classification of intrapartum cardiotocography.	1 week from induction
Duration of labour	Time from the onset of labor (regular contraction every 5 minutes) to the delivery of the baby	1 week from induction
Postpartum hemorrhage above 1000 mL	The investigators will assess whether participants experience blood loss exceeding 1000 mL during delivery and within the first 3 hours postpartum.	1 week from induction
Number of participants with third degree tear of perineum during labour	The investigators will observe the occurrence of third-degree perineal tears during labor. A third-degree tear involves injury to the anal sphincter complex, classified as follows: 3a involves less than 50% of the external anal sphincter (EAS) being torn, 3b involves more than 50% of the EAS being torn, and 3c involves tearing of both the EAS and the internal anal sphincter (IAS).	1 week from induction
Number of participants with fourth degree tear of perineum during labour	The investigators will observe the occurrence of fourth-degree perineal tears during labor. A fourth-degree tear involves injury to the anal sphincter complex (EAS and IAS) as well as the anorectal mucosa.	1 week from induction
Side effects of misoprostol and dinoprostone	The investigators will monitor for the occurrence of the following side effects: nausea, vomiting, high fever, discomfort, diarrhea, and allergic reactions.	1 week from induction
Number of newborns wtih 5-minute APGAR score of less than 7	Infants with a 5-minute APGAR score of less than 7.The Apgar score is a number calculated by scoring the heart rate, respiratory effort, muscle tone, skin color, and reflex irritability of the infant, 5 min after birth. Each of these objective signs can receive 0, 1, or 2 points. The higher is the sum of the points, the better is the condition of the newborn. 5-minute APGAR score of less than 7.	1 week from induction
pH from umbilical artery	A sample will be taken from the umbilical artery after birth for pH analysis.	1 week from induction
Number of newborns admitted to intensive care unit	Infants which will be admitted to the neonatal intensive unit for whatever reason.	3 weeks from induction
Satisfaction with induction	All participants will complete questionnaires designed to assess whether they experienced any feelings of coercion or undue pressure when consenting to labor induction. These surveys will include four questions specifically focused on labor induction, with responses measured using a Likert scale. The questionnaires will be administered after participants have agreed to proceed with the induction process.	1 week from induction
Satisfaction with childbirth	The second questionnaire, the validated Childbirth Experience Questionnaire (CEQ2), assesses satisfaction with the labor and delivery process. Participants will complete the CEQ2 within the first three days postpartum while still admitted to the maternity ward. The survey comprises 22 statements specifically addressing aspects of labor induction and the childbirth experience, with responses evaluated using a Likert scale.	3 weeks from induction

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Estimated): January 22, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: induction of labour; misoprostol; dinoprostone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Oxytocics; Anti-Ulcer Agents; Misoprostol; Dinoprostone
• Other Study ID Numbers: 0120-403/2024-2711-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No