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NCT Number: NCT06794385

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dinoprostone vaginal delivery system

Drug

Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.

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

Primary outcomes

  1. Time from induction to delivery

    Time frame: 1 week from induction

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

Secondary outcomes

  1. Time from induction to spontaneos vaginal delivery

    Time frame: 1 week from induction

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

  2. Time from induction to onset of active labour

    Time frame: 1 week from induction

    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.

  3. Use of oxytocin and its dosage

    Time frame: 1 week from induction

    The investigators will compare the need for oxytocin administration and its dosage, measured in international units (IU).

  4. Use of analgesia during labour

    Time frame: 1 week from induction

    The need for epidural analgesia, remifentanil, N₂O, no analgesia.

  5. Type of delivery

    Time frame: 1 week from induction

    Vaginal birth, Caesarean birth, Vacuum extraction

  6. Hyperstimulation with nonreassuring fetal heart rate tracing

    Time frame: 1 week from induction

    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.

  7. Duration of labour

    Time frame: 1 week from induction

    Time from the onset of labor (regular contraction every 5 minutes) to the delivery of the baby

  8. Postpartum hemorrhage above 1000 mL

    Time frame: 1 week from induction

    The investigators will assess whether participants experience blood loss exceeding 1000 mL during delivery and within the first 3 hours postpartum.

  9. Number of participants with third degree tear of perineum during labour

    Time frame: 1 week from induction

    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).

  10. Number of participants with fourth degree tear of perineum during labour

    Time frame: 1 week from induction

    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.

  11. Side effects of misoprostol and dinoprostone

    Time frame: 1 week from induction

    The investigators will monitor for the occurrence of the following side effects: nausea, vomiting, high fever, discomfort, diarrhea, and allergic reactions.

  12. Number of newborns wtih 5-minute APGAR score of less than 7

    Time frame: 1 week from induction

    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.

  13. pH from umbilical artery

    Time frame: 1 week from induction

    A sample will be taken from the umbilical artery after birth for pH analysis.

  14. Number of newborns admitted to intensive care unit

    Time frame: 3 weeks from induction

    Infants which will be admitted to the neonatal intensive unit for whatever reason.

  15. Satisfaction with induction

    Time frame: 1 week from 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.

  16. Satisfaction with childbirth

    Time frame: 3 weeks from induction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

POLONA PEČLIN

CONTACT

[email protected]

0038615226162

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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