About this trial
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
This trial does not accept healthy volunteersQualifiers
Gestational age between 37 0/7 and 42 0/7 weeks
Singleton pregnancy
Viable fetus in cephalic presentation
Bishop score ≤ 6
Disqualifiers
Age < 18 years
Gestational age < 37 0/7 weeks
Active labor
Spontaneous rupture of membranes
Trial design
Parallel
Treatments tested in this trial
dinoprostone vaginal delivery system
DrugPregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
low dose peroral misoprostol
DrugParticipants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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 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.
Use of oxytocin and its dosage
The investigators will compare the need for oxytocin administration and its dosage, measured in international units (IU).
Use of analgesia during labour
The need for epidural analgesia, remifentanil, N₂O, no analgesia.
Sponsors and contacts
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