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

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

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 Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Procedure: Vaginal Dinoprostone system (Propess®); Procedure: Dilatation balloon

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florent FUCHS, MD PhD; Phone Number: +33467332387; Email: f-fuchs@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier University Hospital
  • Nîmes, France, 30029
    • Nîmes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Florent FUCHS, MD PhD, UH of Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): October 2, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: RECHMPL19_0044; 7756 (Other Identifier: UH Montpellier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No