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

May 12, 2023 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of vaginal deliveries
Time Frame: On the day of the delivery
Rate of vaginal deliveries (both spontaneous or instrumentally assisted)
On the day of the delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of spontaneous vaginal deliveries
Time Frame: On the day of the delivery
Number of spontaneous vaginal deliveries
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
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
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)
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
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
Time Frame: at 12 hours, 24 hours and 48 hours
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
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.
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
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
Time Frame: On the day of the delivery
Number of peridural anaesthesia during labour
On the day of the delivery
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.
On the day of the delivery
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.
On the day of the delivery
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.
On the day of the delivery
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
On the day of the delivery
Rate of uterine rupture
Time Frame: On the day of the delivery
Number of patients with a uterine rupture
On the day of the delivery
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.
On the day of the delivery
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)
One week after day of the delivery
Rate of neonatal asphyxia
Time Frame: On the day of the delivery
Number of fetuses with neonatal asphyxia
On the day of the delivery
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
Up to four days after the delivery
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
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
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
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
On the day of the delivery
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
On the day of the delivery
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)
Up to two weeks after the delivery
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
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Florent FUCHS, MD PhD, UH of Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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