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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 4, 2022

Interventions

  • Procedure: Vaginal Dinoprostone system (Propess®)
    • Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
  • Procedure: Dilatation balloon
    • Labour will be induced using a cervix dilatation balloon as a first strategy

Arms, Groups and Cohorts

  • Active Comparator: Dino-first
    • Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first.
  • Active Comparator: Balloon-first
    • Labour will be induced by the use of a cervix dilatation balloon first.

Clinical Trial Outcome Measures

Primary Measures

  • Rate of vaginal deliveries
    • Time Frame: On the day of the delivery
    • Rate of vaginal deliveries (both spontaneous or instrumentally assisted)

Secondary Measures

  • Rate of spontaneous vaginal deliveries
    • Time Frame: On the day of the delivery
    • Number of spontaneous vaginal deliveries
  • Rate of instrumentally assisted vaginal deliveries, including the reason for the assistance
    • Time Frame: On the day of the delivery
    • Number of instrumentally assisted vaginal deliveries, including the reason for the assistance
  • Rate of C-section including the reason for the C-section
    • Time Frame: On the day of the delivery
    • 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)
  • Timeframe between the beginning of the induction and the beginning of the labour
    • Time Frame: On the day of the delivery
    • Time elapsed between the beginning of the induction and the beginning of the labour
  • Cumulated rate of spontaneous vaginal deliveries
    • Time Frame: at 12 hours, 24 hours and 48 hours
    • Cumulated number of spontaneous vaginal deliveries at 12 hours, 24 hours and 48 hours
  • Rate of labour induction failure
    • Time Frame: On the day of the delivery
    • 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.
  • Rate of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
    • Time Frame: On the day of the delivery
    • Number of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
  • Rate of peridural anaesthesia during labour
    • Time Frame: On the day of the delivery
    • Number of peridural anaesthesia during labour
  • Rate of uterine hyperstimulation without impact on the foetus
    • Time Frame: On the day of the delivery
    • 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.
  • Rate of uterine hyperstimulation with an impact on the foetus
    • Time Frame: On the day of the delivery
    • 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.
  • Rate of uterine hypertonia
    • Time Frame: On the day of the delivery
    • Uterine hypertonia is describes as a frequency of contractions every 2 minutes or less together with a slowing of the foetal heart rate.
  • Rate of post-partum haemorrhagia
    • Time Frame: On the day of the delivery
    • Rate of post-partum haemorrhagia above 500 mL, above 1000 mL, transfusion level and number of packed red blood cells transfused
  • Rate of uterine rupture
    • Time Frame: On the day of the delivery
    • Number of patients with a uterine rupture
  • Rate of intra-uterine infections
    • Time Frame: On the day of the delivery
    • 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.
  • Rate of post-partum infections
    • Time Frame: One week after day of the delivery
    • Number of patients with post-partum infections (body temperature above 38°C with antibiotic treatment, urinary tract infections, bacteriological endometritis)
  • Rate of neonatal asphyxia
    • Time Frame: On the day of the delivery
    • Number of fetuses with neonatal asphyxia
  • Rate of hospitalization in Neonatal intensive care unit
    • Time Frame: Up to four days after the delivery
    • Number of newborn babies hospitalized in Neonatal intensive care unit
  • Rate of proven bacteriological infections in newborn babies
    • Time Frame: Up to four days after the delivery
    • Number of proven bacteriological infections in newborn babies
  • Rate of metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
    • Time Frame: On the day of the delivery
    • Number of women who experienced metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
  • Pain level linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon
    • Time Frame: On the day of the delivery
    • 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
  • Pain level recorded at different times of the labour induction
    • Time Frame: On the day of the delivery
    • 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
  • Assessment of the patient experience of the labour induction
    • Time Frame: Up to four days after the delivery
    • Patient experience will be assessed using the W-DEQ (Wijma Delivery Expectancy/Experience Questionnaire)
  • Assessment of each strategy direct main costs
    • Time Frame: through study completion, an average of 3 years
    • The costs of the treatment and duration of the hospitalization will be measured

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Florent FUCHS, Principal Investigator, UH of Montpellier
  • Overall Contact(s)
    • Florent FUCHS, +33467332387, f-fuchs@chu-montpellier.fr

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