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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
450
Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
Labour will be induced using a cervix dilatation balloon as a first strategy
Montpellier University Hospital
Montpellier, France
Nimes University Hospital
Nîmes, France
Rate of vaginal deliveries
Rate of vaginal deliveries (both spontaneous or instrumentally assisted)
Time frame: On the day of the delivery
Rate of spontaneous vaginal deliveries
Number of spontaneous vaginal deliveries
Time frame: On the day of the delivery
Rate of instrumentally assisted vaginal deliveries, including the reason for the assistance
Number of instrumentally assisted vaginal deliveries, including the reason for the assistance
Time frame: On the day of the delivery
Rate of C-section including the reason for the C-section
Number of C-section including the reason for the C-section. The reasons for the C-section can be : a failure of dilatation at the first stage of the labour (between 0 and 10 cm), an absence of foetal descent at the second stage of labour, a foetal reason or a maternal reason)
Time frame: On the day of the delivery
Timeframe between the beginning of the induction and the beginning of the labour
Time elapsed between the beginning of the induction and the beginning of the labour
Time frame: On the day of the delivery
Cumulated rate of spontaneous vaginal deliveries
Cumulated number of spontaneous vaginal deliveries at 12 hours, 24 hours and 48 hours
Time frame: at 12 hours, 24 hours and 48 hours
Rate of labour induction failure
Rate of labour induction failure is measure by the number of C-sections carried out due to a latency phase (0-6cm), which lasted more than 24 hours, together with the administration of oxytocin for at least 12 to 18 hours after the membranes artifically broke.
Time frame: On the day of the delivery
Rate of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
Number of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
Time frame: On the day of the delivery
Rate of peridural anaesthesia during labour
Number of peridural anaesthesia during labour
Time frame: On the day of the delivery
Rate of uterine hyperstimulation without impact on the foetus
Uterine hyperstimulation is described as a number of contractions of 6 or more within 10 minutes, repeating at least twice). Foetal impact is defined as a slowing of the foetal heart rate.
Time frame: On the day of the delivery
Rate of uterine hyperstimulation with an impact on the foetus
Uterine hyperstimulation is described as a number of contractions of 6 or more within 10 minutes, repeating at least twice). Foetal impact is defined as a slowing of the foetal heart rate.
Time frame: On the day of the delivery
Rate of uterine hypertonia
Uterine hypertonia is describes as a frequency of contractions every 2 minutes or less together with a slowing of the foetal heart rate.
Time frame: On the day of the delivery
Rate of post-partum haemorrhagia
Rate of post-partum haemorrhagia above 500 mL, above 1000 mL, transfusion level and number of packed red blood cells transfused
Time frame: On the day of the delivery
Rate of uterine rupture
Number of patients with a uterine rupture
Time frame: On the day of the delivery
Rate of intra-uterine infections
Number of patients with intra-uterine infections (body temperature above 38°C measured twice within 30 minutes, associated to 2 criteria within the followings: foetal tachycardia above 160 beats per minute, pain of the uterus or painful uterus contractions ou spontaneous labour induction, or purulent amniotic fluid.
Time frame: On the day of the delivery
Rate of post-partum infections
Number of patients with post-partum infections (body temperature above 38°C with antibiotic treatment, urinary tract infections, bacteriological endometritis)
Time frame: One week after day of the delivery
Rate of neonatal asphyxia
Number of fetuses with neonatal asphyxia
Time frame: On the day of the delivery
Rate of hospitalization in Neonatal intensive care unit
Number of newborn babies hospitalized in Neonatal intensive care unit
Time frame: Up to four days after the delivery
Rate of proven bacteriological infections in newborn babies
Number of proven bacteriological infections in newborn babies
Time frame: Up to four days after the delivery
Rate of metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
Number of women who experienced metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
Time frame: On the day of the delivery
Pain level linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon
Measurement of Pain will be made using an Visual Analog Scale (VAS). The pain level will be linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon
Time frame: On the day of the delivery
Pain level recorded at different times of the labour induction
Measurement will be made using a Visual Analog Scale (VAS) and will be recorded at different times of the dilatation balloon or the dinoprostone vaginal pad set up
Time frame: On the day of the delivery
Assessment of the patient experience of the labour induction
Patient experience will be assessed using the W-DEQ (Wijma Delivery Expectancy/Experience Questionnaire)
Time frame: Up to two weeks after the delivery
Assessment of each strategy direct main costs
The costs of the treatment and duration of the hospitalization will be measured
Time frame: through study completion, an average of 3 years
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