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Completed

NCT Number: NCT04452747

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal Dinoprostone system (Propess®)

Procedure

Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy

Dilatation balloon

Procedure

Labour will be induced using a cervix dilatation balloon as a first strategy

Primary outcomes

  1. Rate of vaginal deliveries

    Time frame: On the day of the delivery

    Rate of vaginal deliveries (both spontaneous or instrumentally assisted)

Secondary outcomes

  1. Rate of spontaneous vaginal deliveries

    Time frame: On the day of the delivery

    Number of spontaneous vaginal deliveries

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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.

  7. 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

  8. Rate of peridural anaesthesia during labour

    Time frame: On the day of the delivery

    Number of peridural anaesthesia during labour

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. Rate of uterine rupture

    Time frame: On the day of the delivery

    Number of patients with a uterine rupture

  14. 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.

  15. 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)

  16. Rate of neonatal asphyxia

    Time frame: On the day of the delivery

    Number of fetuses with neonatal asphyxia

  17. 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

  18. 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

  19. 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)

  20. 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

  21. 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

  22. Assessment of the patient experience of the labour induction

    Time frame: Up to two weeks after the delivery

    Patient experience will be assessed using the W-DEQ (Wijma Delivery Expectancy/Experience Questionnaire)

  23. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: BESTWAY

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 30, 2020
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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