Induction of LabourPhase 4NCT06794385
Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
A Phase 4 study testing dinoprostone vaginal delivery system and low dose peroral misoprostol in people with Induction of Labour, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induction of Labour
- What is being tested?
- dinoprostone vaginal delivery system and low dose peroral misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 22 Jan 2025to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Induction of Labour
- Being tested
- dinoprostone vaginal delivery system, low dose peroral misoprostol
- Keywords
- misoprostol, induction of labour, dinoprostone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dinoprostone vaginal delivery systemDrug
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction.
low dose peroral misoprostolDrug
Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Group undergoing labor induction with the dinoprostone vaginal delivery system | Active comparator | Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction. The medication will be inserted into the posterior fornix of the vagina, with the active substance being released over a 24-hour period. Maternal and fetal health will be monitored during their stay on the ward. Upon the onset of contractions or any signs of fetal distress, patients will be transferred to the delivery unit. If labor does not commence and the cervix remains unfavorable after 24 hours, a new vaginal delivery system will be inserted for an additional 24 hours. If no progress is observed within 48 hours of induction, a mechanical method for labor induction or cesarean delivery will be employed. After delivery, women will complete a questionnaire to assess their satisfaction with the childbirth experience. Receives: Drug: dinoprostone vaginal delivery system |
| Group undergoing labor induction with the low dose peroral misoprostol | Active comparator | Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours until adequate uterine contractions and a favorable cervical condition are achieved. A maximum of 8 doses will be administered on the first day. If labor does not commence and the cervix remains unfavorable, a second induction cycle will be initiated the following day. If no progress occurrs after 48 hours from the induction, participants will undergo cesarean delivery, or alternative mechanical induction method will be used. Following delivery, participants will complete a questionnaire to assess their satisfaction with the childbirth experience. Receives: Drug: low dose peroral misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week from induction
Secondary outcomes (16)
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
Measured: 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.
Measured: 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).
Measured: 1 week from induction
Use of analgesia during labour
The need for epidural analgesia, remifentanil, N₂O, no analgesia.
Measured: 1 week from induction
Type of delivery
Vaginal birth, Caesarean birth, Vacuum extraction
Measured: 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.
Measured: 1 week from induction
Duration of labour
Time from the onset of labor (regular contraction every 5 minutes) to the delivery of the baby
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week from induction
pH from umbilical artery
A sample will be taken from the umbilical artery after birth for pH analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks from induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start22 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LabourStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794385
- Sponsor's protocol ID
- 0120-403/2024-2711-3
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
- ClinicalTrials.gov ID
- NCT06794385
- Acronym / sponsor ID
- 0120-403/2024-2711-3
- Conditions
- Induction of Labour
- Keywords
- misoprostol, induction of labour, dinoprostone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 22 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group undergoing labor induction with the dinoprostone vaginal delivery system | Active comparator | Drug: dinoprostone vaginal delivery systemPregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction. The medication will be inserted into the posterior fornix of the vagina, with the active substance being released over a 24-hour period. Maternal and fetal health will be monitored during their stay on the ward. Upon the onset of contractions or any signs of fetal distress, patients will be transferred to the delivery unit. If labor does not commence and the cervix remains unfavorable after 24 hours, a new vaginal delivery system will be inserted for an additional 24 hours. If no progress is observed within 48 hours of induction, a mechanical method for labor induction or cesarean delivery will be employed. After delivery, women will complete a questionnaire to assess their satisfaction with the childbirth experience. |
| Group undergoing labor induction with the low dose peroral misoprostol | Active comparator | Drug: low dose peroral misoprostolParticipants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours until adequate uterine contractions and a favorable cervical condition are achieved. A maximum of 8 doses will be administered on the first day. If labor does not commence and the cervix remains unfavorable, a second induction cycle will be initiated the following day. If no progress occurrs after 48 hours from the induction, participants will undergo cesarean delivery, or alternative mechanical induction method will be used. Following delivery, participants will complete a questionnaire to assess their satisfaction with the childbirth experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Age < 18 years
- Gestational age < 37 0/7 weeks
- Active labor
- Spontaneous rupture of membranes
- Non-reassuring CTG findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dinoprostone vaginal delivery systemPregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction. | Drug | Group undergoing labor induction with the dinoprostone vaginal delivery system |
| low dose peroral misoprostolParticipants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours | Drug | Group undergoing labor induction with the low dose peroral misoprostol |
Primary outcome
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
16 secondary outcomes
Time from induction to spontaneos vaginal delivery
Time frame: 1 week from induction
Time from induction to onset of active labour
Time frame: 1 week from induction
Use of oxytocin and its dosage
Time frame: 1 week from induction
Use of analgesia during labour
Time frame: 1 week from induction
Type of delivery
Time frame: 1 week from induction
Hyperstimulation with nonreassuring fetal heart rate tracing
Time frame: 1 week from induction
Duration of labour
Time frame: 1 week from induction
Postpartum hemorrhage above 1000 mL
Time frame: 1 week from induction
Number of participants with third degree tear of perineum during labour
Time frame: 1 week from induction
Number of participants with fourth degree tear of perineum during labour
Time frame: 1 week from induction
Side effects of misoprostol and dinoprostone
Time frame: 1 week from induction
Number of newborns wtih 5-minute APGAR score of less than 7
Time frame: 1 week from induction
pH from umbilical artery
Time frame: 1 week from induction
Number of newborns admitted to intensive care unit
Time frame: 3 weeks from induction
Satisfaction with induction
Time frame: 1 week from induction
Satisfaction with childbirth
Time frame: 3 weeks from induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No. IPD will be available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dinoprostone vaginal delivery system and low dose peroral misoprostol in people with Induction of Labour, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact POLONA PEČLIN (0038615226162, polona.peclin@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from induction to delivery (time frame: 1 week from induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.