Status:
COMPLETED
Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Labour induction is an obstetrical procedure, which artificially starts the process of cervix dilation, in order to induce labour. Several methods of labour induction exist : mechanical ones (using di...
Eligibility Criteria
Inclusion
- Women with singleton pregnancy
- 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
- Previous C-section or uterine incision
- 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
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04452747
Start Date
November 16 2020
End Date
March 1 2023
Last Update
May 15 2023
Active Locations (2)
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1
Montpellier University Hospital
Montpellier, France, 34295
2
Nimes University Hospital
Nîmes, France, 30029