Induction of LaborMISODINONCT04955847
Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
An observational study of Induction of Labor and Vaginal Delivery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induction of Labor, Vaginal Delivery, Cesarean Section
- Type of treatment
- Pill or oral medicine
- How many people
- 706 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2021to 8 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: all patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six)
Who may be able to join
- age of patient> 18 years
- patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six).
Who cannot join
- intrauterine fetal death,
- preterm pregnancy,
- scarred uterus
- contraindications to vaginal delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction.
Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term.
The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.
- Conditions
- Induction of Labor, Vaginal Delivery, Cesarean Section
- Keywords
- Induction of Labor, PGE1, PGE2, vaginal delivery, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PGE2 | In period 1, the service protocol for induction at term on an unfavorable cervix indicated the use of a PGE2. In nulliparous women, Propess® was introduced intra-vaginally for 24 hours or until regular painful uterine contractions occurred. In the case of a multiparous woman, Prostine® gel, one or two mg depending on the cervical conditions at the time of induction, was introduced intravaginally and the cervix was reassessed after six hours. If the cervix remained unfavorable and the kinetics of the contractions were not optimal, a new dose of Prostine® one or two mg was administered to the patient. | |
| misoprostol | In period 2, patients who were induced with an unfavorable cervix at term were induced with misoprostol. Regardless of parity, the patient received oral misoprostol 25 μg, one tablet orally every two hours until a maximum of eight tablets per day, or 200 µg, was reached, with cessation of the tablets when painful, regular contractions were obtained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of vaginal deliveries within 24hours patient number in both groups
Measured: 24 hours
Secondary outcomes (3)
Variation of Cesarean section patient number in both groups
Measured: 24 hours
Variation of indications for cesarean section in both groups
Measured: 24 hours
Variation of uterine contractility abnormalities in both groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start15 Jan 2021
- Primary completion8 May 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955847
- Sponsor's protocol ID
- PI2021_843_0070
- Acronym
- MISODINO
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
- ClinicalTrials.gov ID
- NCT04955847
- Acronym / sponsor ID
- MISODINO / PI2021_843_0070
- Conditions
- Induction of Labor, Vaginal Delivery, Cesarean Section
- Keywords
- Induction of Labor, PGE1, PGE2, vaginal delivery, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 9 Jul 2021 (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.
Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction.
Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term.
The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGE2 | – | –In period 1, the service protocol for induction at term on an unfavorable cervix indicated the use of a PGE2. In nulliparous women, Propess® was introduced intra-vaginally for 24 hours or until regular painful uterine contractions occurred. In the case of a multiparous woman, Prostine® gel, one or two mg depending on the cervical conditions at the time of induction, was introduced intravaginally and the cervix was reassessed after six hours. If the cervix remained unfavorable and the kinetics of the contractions were not optimal, a new dose of Prostine® one or two mg was administered to the patient. |
| misoprostol | – | –In period 2, patients who were induced with an unfavorable cervix at term were induced with misoprostol. Regardless of parity, the patient received oral misoprostol 25 μg, one tablet orally every two hours until a maximum of eight tablets per day, or 200 µg, was reached, with cessation of the tablets when painful, regular contractions were obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six)
Key inclusion criteria (2 listed)
- age of patient> 18 years
- patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six).
Key exclusion criteria (4 listed)
- intrauterine fetal death,
- preterm pregnancy,
- scarred uterus
- contraindications to vaginal delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of vaginal deliveries within 24hours patient number in both groups
Time frame: 24 hours
3 secondary outcomes
Variation of Cesarean section patient number in both groups
Time frame: 24 hours
Variation of indications for cesarean section in both groups
Time frame: 24 hours
Variation of uterine contractility abnormalities in both groups
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Induction of Labor
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induction of Labor and Vaginal Delivery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jun 2026. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of vaginal deliveries within 24hours patient number in both groups (time frame: 24 hours). 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 12 Jun 2026.