Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies (BESTWAY)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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 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
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
450 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal