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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours
UMC Ljubljana
Ljubljana, Slovenia
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
Time frame: 1 week from induction
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
Time frame: 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.
Time frame: 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).
Time frame: 1 week from induction
Use of analgesia during labour
The need for epidural analgesia, remifentanil, N₂O, no analgesia.
Time frame: 1 week from induction
Type of delivery
Vaginal birth, Caesarean birth, Vacuum extraction
Time frame: 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.
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Time frame: 1 week from induction
Duration of labour
Time from the onset of labor (regular contraction every 5 minutes) to the delivery of the baby
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week from induction
pH from umbilical artery
A sample will be taken from the umbilical artery after birth for pH analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks from induction