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

Study Overview
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Brief Summary
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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.

Official Title
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Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Clinical Trial of Two Strategies (DINO-FIRST Versus BALLON-FIRST)

Conditions
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Pregnancy Related

Intervention / Treatment
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* Procedure: Vaginal Dinoprostone system (Propess®)
* Procedure: Dilatation balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dino-first<br>Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first. | Procedure: Vaginal Dinoprostone system (Propess®)<br>* Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy<br>|
| Active Comparator: Balloon-first<br>Labour will be induced by the use of a cervix dilatation balloon first. | Procedure: Dilatation balloon<br>* Labour will be induced using a cervix dilatation balloon as a first strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of vaginal deliveries | Rate of vaginal deliveries (both spontaneous or instrumentally assisted) | On the day of the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of spontaneous vaginal deliveries | Number of spontaneous vaginal deliveries | 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 | 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) | 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 | 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 | 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. | 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 | On the day of the delivery | 
| Rate of peridural anaesthesia during labour | Number of peridural anaesthesia during labour | 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. | 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. | 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. | 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 | On the day of the delivery | 
| Rate of uterine rupture | Number of patients with a uterine rupture | 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. | 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) | One week after day of the delivery | 
| Rate of neonatal asphyxia | Number of fetuses with neonatal asphyxia | On the day of the delivery | 
| Rate of hospitalization in Neonatal intensive care unit | Number of newborn babies hospitalized in Neonatal intensive care unit | Up to four days after the delivery | 
| Rate of proven bacteriological infections in newborn babies | Number of proven bacteriological infections in newborn babies | 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) | 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 | 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 | 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) | 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 | through study completion, an average of 3 years |