NCT02477085

Brief Summary

Since it is a frequent intervention in Obstetrics, labor induction is rarely evaluated from national population-based cohorts. The study aims to assess the frequency of different induction methods used in France from a prospective population-based cohort of women with an induced labor. Maternal, fetal and neonatal outcomes will be compared between the different induction methods. Moreover the adhesion to national clinical guidelines concerning the induction of labor will be studied from this population-based cohort. Finally the women satisfaction will be assessed according to the induction method used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,049

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

June 10, 2015

Last Update Submit

November 17, 2025

Conditions

Induction of Labor

Keywords

Laborinductiondeliveryprostaglandinsoxytocinamniotomyballoon catheter

Outcome Measures

Primary Outcomes (1)

  • Composite measure of induction methods

    * Amniotomy * Amniotomy and oxytocin * Prostaglandins (PGE1, PGE2) * Balloon catheter For each of these methods, evaluation of these composite criteria * Frequency * Posology * Way of administration * Indication of labor induction

    Beginning of labor induction

Secondary Outcomes (3)

  • Composite measure of maternal morbidity

    Labor induction

  • Composite measure of fetal and neonatal mortality and morbidity

    from induction up to average 7 days post delivery

  • Women's satisfaction Questionnaire

    8 weeks after delivery

Study Arms (1)

all women with an induced labor

prospective population-based cohort of all women who have an induced labor during one month in seven perinatal networks

Other: all women with an induced labor

Interventions

all women with an induced laborOTHER

all women who have an induced labor

all women with an induced labor

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all women who have an induced labor

You may qualify if:

  • patient who has a labor induction
  • with a live fetus at the beginning of induction
  • patient who did not have any opposition to use her medical and personal data or her child's medical data for research

You may not qualify if:

  • in utero fetal death
  • termination of pregnancy
  • patient's refusal to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP

Paris, 75014, France

Location

Related Publications (3)

  • Jochum F, Le Ray C, Blanc-Petitjean P, Langer B, Meyer N, Severac F, Sananes N. Externally Validated Score to Predict Cesarean Delivery After Labor Induction With Cervi Ripening. Obstet Gynecol. 2019 Sep;134(3):502-510. doi: 10.1097/AOG.0000000000003405.

    PMID: 31403585RESULT

  • Blanc-Petitjean P, Schmitz T, Salome M, Goffinet F, Le Ray C; MEDIP Study Group. Target populations to reduce cesarean rates after induced labor: A national population-based cohort study. Acta Obstet Gynecol Scand. 2020 Mar;99(3):406-412. doi: 10.1111/aogs.13751. Epub 2019 Nov 19.

    PMID: 31628852RESULT

  • Blanc-Petitjean P, Salome M, Dupont C, Crenn-Hebert C, Gaudineau A, Perrotte F, Raynal P, Clouqueur E, Beucher G, Carbonne B, Goffinet F, Le Ray C. Labour induction practices in France: A population-based declarative survey in 94 maternity units. J Gynecol Obstet Hum Reprod. 2018 Feb;47(2):57-62. doi: 10.1016/j.jogoh.2017.11.006. Epub 2017 Nov 28.

    PMID: 29196154RESULT

Study Officials

  • Camille Le Ray

    Assistance publique des Hôpitaux de Paris (APHP)

    PRINCIPAL INVESTIGATOR

  • François Goffinet

    Assistance publique des Hôpitaux de Paris (APHP)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 22, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)