Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor
MADUTER
1 other identifier
interventional
198
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2014
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 9, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedNovember 16, 2018
November 1, 2018
3.4 years
November 9, 2018
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful vaginal delivery within 24 hours
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
24 hours since induction was started
Secondary Outcomes (4)
Successful cervical ripening within 24 hours
24 hours since induction was started
Interval time from induction to delivery
Hours passed between induction of labor until delivery within 72 hours
Need for a second induction
Assessed 24 hours since induction of labor was started
Vaginal delivery rate
Since labor induction had started until delivery had ocurred within 72 hours
Study Arms (2)
Misoprostol
ACTIVE COMPARATORGroup of women allocated to misoprostol induction.
Dinoprostone
ACTIVE COMPARATORGroup of women allocated to dinoprostone induction.
Interventions
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Eligibility Criteria
You may qualify if:
- Singleton uncomplicated pregnancy
- Nulliparity
- Live fetus
- days of gestational age or above
- Abscence of contraindication for vaginal delivery
- Bishop score lower than 6
You may not qualify if:
- Multiple pregnancy
- Multiparity
- Stillbirth
- Oligohydramnios
- Suspected fetal distress
- Severe asthma
- Intolerance/allergy to prostaglandins
- Contraindication for vaginal birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30723912DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Unit of Maternal-Fetal Medicine
Study Record Dates
First Submitted
November 9, 2018
First Posted
November 16, 2018
Study Start
June 1, 2014
Primary Completion
October 20, 2017
Study Completion
November 1, 2017
Last Updated
November 16, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share