Clinical trial NCT04452747: Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies
Official title: Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Clinical Trial of Two Strategies (DINO-FIRST Versus BALLON-FIRST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of vaginal deliveries
timeFrame: On the day of the delivery
Secondary outcomes:
measure: Rate of spontaneous vaginal deliveries
timeFrame: On the day of the delivery
measure: Rate of instrumentally assisted vaginal deliveries, including the reason for the assistance
timeFrame: On the day of the delivery
measure: Rate of C-section including the reason for the C-section
timeFrame: On the day of the delivery
measure: Timeframe between the beginning of the induction and the beginning of the labour
timeFrame: On the day of the delivery
measure: Cumulated rate of spontaneous vaginal deliveries
timeFrame: at 12 hours, 24 hours and 48 hours
measure: Rate of labour induction failure
timeFrame: On the day of the delivery
measure: Rate of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
timeFrame: On the day of the delivery
measure: Rate of peridural anaesthesia during labour
timeFrame: On the day of the delivery
measure: Rate of uterine hyperstimulation without impact on the foetus
timeFrame: On the day of the delivery
measure: Rate of uterine hyperstimulation with an impact on the foetus
timeFrame: On the day of the delivery
measure: Rate of uterine hypertonia
timeFrame: On the day of the delivery
measure: Rate of post-partum haemorrhagia
timeFrame: On the day of the delivery
measure: Rate of uterine rupture
timeFrame: On the day of the delivery
measure: Rate of intra-uterine infections
timeFrame: On the day of the delivery
measure: Rate of post-partum infections
timeFrame: One week after day of the delivery
measure: Rate of neonatal asphyxia
timeFrame: On the day of the delivery
measure: Rate of hospitalization in Neonatal intensive care unit
timeFrame: Up to four days after the delivery
measure: Rate of proven bacteriological infections in newborn babies
timeFrame: Up to four days after the delivery
measure: Rate of metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
timeFrame: On the day of the delivery
measure: Pain level linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon
timeFrame: On the day of the delivery
measure: Pain level recorded at different times of the labour induction
timeFrame: On the day of the delivery
measure: Assessment of the patient experience of the labour induction
timeFrame: Up to two weeks after the delivery
measure: Assessment of each strategy direct main costs
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nîmes
country: France
facility: Nimes University Hospital
Study officials:
affiliation: UH of Montpellier
name: Florent FUCHS, MD PhD
role: STUDY_DIRECTOR
References: