Pregnancy RelatedBESTWAYNCT04452747
Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies
A study testing Vaginal Dinoprostone system (Propess®) and Dilatation balloon in people with Pregnancy Related, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Vaginal Dinoprostone system (Propess®) and Dilatation balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Nov 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Montpellier University Hospital
Montpellier, 34295
Nimes University Hospital
Nîmes, 30029
About this study
Official title: 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.
- Conditions
- Pregnancy Related
- Being tested
- Vaginal Dinoprostone system (Propess®), Dilatation balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Dinoprostone system (Propess®)Procedure or surgery
Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
Dilatation balloonProcedure or surgery
Labour will be induced using a cervix dilatation balloon as a first strategy
| Study group | Role | What they receive |
|---|---|---|
| Dino-first | Active comparator | Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first. Receives: Procedure: Vaginal Dinoprostone system (Propess®) |
| Balloon-first | Active comparator | Labour will be induced by the use of a cervix dilatation balloon first. Receives: Procedure: Dilatation balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of vaginal deliveries
Rate of vaginal deliveries (both spontaneous or instrumentally assisted)
Measured: On the day of the delivery
Secondary outcomes (23)
Rate of spontaneous vaginal deliveries
Number of spontaneous vaginal deliveries
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: On the day of the delivery
Rate of peridural anaesthesia during labour
Number of peridural anaesthesia during labour
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: On the day of the delivery
Rate of uterine rupture
Number of patients with a uterine rupture
Measured: 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.
Measured: 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)
Measured: One week after day of the delivery
Rate of neonatal asphyxia
Number of fetuses with neonatal asphyxia
Measured: On the day of the delivery
Rate of hospitalization in Neonatal intensive care unit
Number of newborn babies hospitalized in Neonatal intensive care unit
Measured: Up to four days after the delivery
Rate of proven bacteriological infections in newborn babies
Number of proven bacteriological infections in newborn babies
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start16 Nov 2020
- Primary completion2 Oct 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, MD PhD, Study director, UH of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452747
- Sponsor's protocol ID
- RECHMPL19_0044
- Other IDs
- 7756
- Acronym
- BESTWAY
- Status last verified
- May 2023
- First submitted
- 23 Jun 2020
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Clinical Trial of Two Strategies (DINO-FIRST Versus BALLON-FIRST)
- ClinicalTrials.gov ID
- NCT04452747
- Acronym / sponsor ID
- BESTWAY / RECHMPL19_0044
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dino-first | Active comparator | Procedure: Vaginal Dinoprostone system (Propess®)Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first. |
| Balloon-first | Active comparator | Procedure: Dilatation balloonLabour will be induced by the use of a cervix dilatation balloon first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Dinoprostone system (Propess®)Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy | Procedure or surgery | Dino-first |
| Dilatation balloonLabour will be induced using a cervix dilatation balloon as a first strategy | Procedure or surgery | Balloon-first |
Primary outcome
Rate of vaginal deliveries
Time frame: On the day of the delivery
Rate of vaginal deliveries (both spontaneous or instrumentally assisted)
23 secondary outcomes
Rate of spontaneous vaginal deliveries
Time frame: On the day of the delivery
Rate 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
Time frame: On the day of the delivery
Timeframe 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
Time frame: at 12 hours, 24 hours and 48 hours
Rate of labour induction failure
Time frame: On the day of the delivery
Rate 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
Time frame: On the day of the delivery
Rate of uterine hyperstimulation without impact on the foetus
Time frame: On the day of the delivery
Rate of uterine hyperstimulation with an impact on the foetus
Time frame: On the day of the delivery
Rate of uterine hypertonia
Time frame: On the day of the delivery
Rate of post-partum haemorrhagia
Time frame: On the day of the delivery
Rate of uterine rupture
Time frame: On the day of the delivery
Rate of intra-uterine infections
Time frame: On the day of the delivery
Rate of post-partum infections
Time frame: One week after day of the delivery
Rate of neonatal asphyxia
Time frame: On the day of the delivery
Rate of hospitalization in Neonatal intensive care unit
Time frame: Up to four days after the delivery
Rate 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)
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
Time frame: On the day of the delivery
Pain level recorded at different times of the labour induction
Time frame: On the day of the delivery
Assessment of the patient experience of the labour induction
Time frame: Up to two weeks after the delivery
Assessment of each strategy direct main costs
Time frame: through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent FUCHS, MD PhD study director
UH of Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Dinoprostone system (Propess®) and Dilatation balloon in people with Pregnancy Related, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of vaginal deliveries (time frame: On the day of the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.