Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies
NCT ID: NCT04452747
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
450 participants
INTERVENTIONAL
2020-11-16
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Dino-first
Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first.
Vaginal Dinoprostone system (Propess®)
Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
Balloon-first
Labour will be induced by the use of a cervix dilatation balloon first.
Dilatation balloon
Labour will be induced using a cervix dilatation balloon as a first strategy
Interventions
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Vaginal Dinoprostone system (Propess®)
Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
Dilatation balloon
Labour will be induced using a cervix dilatation balloon as a first strategy
Eligibility Criteria
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Inclusion Criteria
* Fetus with cephalic presentation
* Intact membranes between 37 and 42 weeks of amenorrhea
* Medical indication for labour induction according to the "Haute Autorité de Santé" (HAS) guidelines
* Unfavourable cervix (Bishop scoring \< 7)
* Age \> 18 years-old
* Person affiliated to a healthcare system
* Good understanding of the French language
Exclusion Criteria
* Placenta previa
* Metrorrhagia of unknown origin
* Lethal foetal abnormality
* Hyperreactivity to one of the molecules used for the induction (dinoprostone or oxytocin) or to latex
* Subject participants to another biomedical research
* Subject under legal guardianship or curatorship
18 Years
FEMALE
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Florent FUCHS, MD PhD
Role: STUDY_DIRECTOR
UH of Montpellier
Locations
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Montpellier University Hospital
Montpellier, , France
Nimes University Hospital
Nîmes, , France
Countries
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Other Identifiers
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7756
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL19_0044
Identifier Type: -
Identifier Source: org_study_id
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