Clinical trial NCT06794385: Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
Official title: Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Induction of Labour
Keywords: misoprostol
induction of labour
dinoprostone
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from induction to delivery
timeFrame: 1 week from induction
Secondary outcomes:
measure: Time from induction to spontaneos vaginal delivery
timeFrame: 1 week from induction
measure: Time from induction to onset of active labour
timeFrame: 1 week from induction
measure: Use of oxytocin and its dosage
timeFrame: 1 week from induction
measure: Use of analgesia during labour
timeFrame: 1 week from induction
measure: Type of delivery
timeFrame: 1 week from induction
measure: Hyperstimulation with nonreassuring fetal heart rate tracing
timeFrame: 1 week from induction
measure: Duration of labour
timeFrame: 1 week from induction
measure: Postpartum hemorrhage above 1000 mL
timeFrame: 1 week from induction
measure: Number of participants with third degree tear of perineum during labour
timeFrame: 1 week from induction
measure: Number of participants with fourth degree tear of perineum during labour
timeFrame: 1 week from induction
measure: Side effects of misoprostol and dinoprostone
timeFrame: 1 week from induction
measure: Number of newborns wtih 5-minute APGAR score of less than 7
timeFrame: 1 week from induction
measure: pH from umbilical artery
timeFrame: 1 week from induction
measure: Number of newborns admitted to intensive care unit
timeFrame: 3 weeks from induction
measure: Satisfaction with induction
timeFrame: 1 week from induction
measure: Satisfaction with childbirth
timeFrame: 3 weeks from induction
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
References: