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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Medical Centre Ljubljana

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Group undergoing labor induction with the dinoprostone vaginal delivery systemActive comparator 1 intervention
Group B: Group undergoing labor induction with the low dose peroral misoprostolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Use of analgesia during labour

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

Time frame
1 week from induction

Other outcomes

Sponsors and contacts

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