Induced LaborPhase 4MADUTERNCT03744364
Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor
A Phase 4 study testing Misoprostol 25 mcg and Dinoprostone 10mg in people with Induced Labor and Cervical Ripening, run by Hospital Miguel Servet.
Trial summary
Purpose: To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Labor, Cervical Ripening, Obstetric Labor
- What is being tested?
- Misoprostol 25 mcg and Dinoprostone 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Nov 2017
- Phase
- Phase 4
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton uncomplicated pregnancy
- Nulliparity
- Live fetus
- 286 days of gestational age or above
- Abscence of contraindication for vaginal delivery
- Bishop score lower than 6
Who cannot join
- Multiple pregnancy
- Multiparity
- Stillbirth
- Oligohydramnios
- Suspected fetal distress
- Severe asthma
- Intolerance/allergy to prostaglandins
- Contraindication for vaginal birth
About this study
Official title: Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial
Purpose:
To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.
Methods:
The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.
- Conditions
- Induced Labor, Cervical Ripening, Obstetric Labor, Pregnancy
- Being tested
- Misoprostol 25 mcg, Dinoprostone 10mg
- Keywords
- Dinoprostone, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 25 mcgDrug
Also called Misoprostol induction
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
Dinoprostone 10mgDrug
Also called Dinoprostone induction
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | Group of women allocated to misoprostol induction. Receives: Drug: Misoprostol 25 mcg |
| Dinoprostone | Active comparator | Group of women allocated to dinoprostone induction. Receives: Drug: Dinoprostone 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful vaginal delivery within 24 hours
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
Measured: 24 hours since induction was started
Secondary outcomes (4)
Successful cervical ripening within 24 hours
Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started
Measured: 24 hours since induction was started
Interval time from induction to delivery
Time passed since induction of labor started until delivery
Measured: Hours passed between induction of labor until delivery within 72 hours
Need for a second induction
Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor
Measured: Assessed 24 hours since induction of labor was started
Vaginal delivery rate
Percentage of women that achieve vaginal delivery
Measured: Since labor induction had started until delivery had ocurred within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Jun 2014
- Primary completion20 Oct 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced LaborStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Manuel Campillos Maza, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744364
- Sponsor's protocol ID
- JMC-PGE-2014-01
- Acronym
- MADUTER
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Bonrostro Torralba C, Tejero Cabrejas EL, Envid Lazaro BM, Franco Royo MJ, Roca Arquillue M, Campillos Maza JM. Low-dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial. Acta Obstet Gynecol Scand. 2019 Jul;98(7):913-919. doi: 10.1111/aogs.13556. Epub 2019 Feb 24.
PubMed 30723912
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03744364
- Acronym / sponsor ID
- MADUTER / JMC-PGE-2014-01
- Conditions
- Induced Labor, Cervical Ripening, Obstetric Labor, Pregnancy
- Keywords
- Dinoprostone, Misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 16 Nov 2018 (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.
Purpose:
To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.
Methods:
The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: Misoprostol 25 mcgGroup of women allocated to misoprostol induction. |
| Dinoprostone | Active comparator | Drug: Dinoprostone 10mgGroup of women allocated to dinoprostone induction. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton uncomplicated pregnancy
- Nulliparity
- Live fetus
- 286 days of gestational age or above
- Abscence of contraindication for vaginal delivery
Key exclusion criteria (8 listed)
- Multiple pregnancy
- Multiparity
- Stillbirth
- Oligohydramnios
- Suspected fetal distress
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 |
|---|---|---|
| Misoprostol 25 mcgAlso: Misoprostol inductionTo determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor. | Drug | Misoprostol |
| Dinoprostone 10mgAlso: Dinoprostone inductionTo determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor. | Drug | Dinoprostone |
Primary outcome
Successful vaginal delivery within 24 hours
Time frame: 24 hours since induction was started
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
4 secondary outcomes
Successful cervical ripening within 24 hours
Time frame: 24 hours since induction was started
Interval time from induction to delivery
Time frame: Hours passed between induction of labor until delivery within 72 hours
Need for a second induction
Time frame: Assessed 24 hours since induction of labor was started
Vaginal delivery rate
Time frame: Since labor induction had started until delivery had ocurred within 72 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 16 Nov 2018.
- Derived from this study: PubMed 30723912De Bonrostro Torralba C, Tejero Cabrejas EL, Envid Lazaro BM, Franco Royo MJ, Roca Arquillue M, Campillos Maza JM. Low-dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial. Acta Obstet Gynecol Scand. 2019 Jul;98(7):913-919. doi: 10.1111/aogs.13556. Epub 2019 Feb 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol 25 mcg and Dinoprostone 10mg in people with Induced Labor and Cervical Ripening, run by Hospital Miguel Servet.
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 8 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Successful vaginal delivery within 24 hours (time frame: 24 hours since induction was started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744364, which also lists 1 linked publication.
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 16 Nov 2018.