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

NCT04452747 | Completed

• 2 other identifiers: RECHMPL19_00447756
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Rate of vaginal deliveries

  Rate of vaginal deliveries (both spontaneous or instrumentally assisted)

  On the day of the delivery

Secondary Outcomes (23)

• Rate of spontaneous vaginal deliveries

  On the day of the delivery

• Rate 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

  On the day of the delivery

• Timeframe between the beginning of the induction and the beginning of the labour

  On the day of the delivery

• Cumulated rate of spontaneous vaginal deliveries

  at 12 hours, 24 hours and 48 hours

Study Arms (2)

Dino-first

ACTIVE COMPARATOR

Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first.

Procedure: Vaginal Dinoprostone system (Propess®)

Balloon-first

ACTIVE COMPARATOR

Labour will be induced by the use of a cervix dilatation balloon first.

Procedure: Dilatation balloon

Interventions

Vaginal Dinoprostone system (Propess®) PROCEDURE

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

Dino-first

Dilatation balloon PROCEDURE

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

Balloon-first

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Montpellier University Hospital

Montpellier, 34295, France

Location

Nimes University Hospital

Nîmes, 30029, France

Location

Study Officials

• Florent FUCHS, MD PhD

  UH of Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 30, 2020
• Study Start: November 16, 2020
• Primary Completion: October 2, 2022
• Study Completion: March 1, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)