Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    390
  • sponsor
    University Hospital, Montpellier
Updated on 25 March 2021
oxytocin
induction of labor

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 dilatation balloons) or pharmacological ones (using prostaglandins or oxytocin). This trial aims to compare, in case of non-favourable cervix, the strategy of labour induction using the Propess method first (Dino-first) versus the strategy beginning with the use of a dilatation balloon (Ballon-first), with respect of the usual practice and the current guidelines.

Details
Condition Pregnancy Related
Treatment Vaginal Dinoprostone system (Propess®), Dilatation balloon
Clinical Study IdentifierNCT04452747
SponsorUniversity Hospital, Montpellier
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Autorit de Sant" (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

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
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