Methods of Labor Induction and Perinatal Outcomes

NCT ID: NCT02477085

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3049 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Labor induction concerns about 22% of deliveries in France, according to the the 2010 French national perinatal survey. Labor induction could be associated with a higher risk of fetal and maternal complications, justifying its assessment from a population-based prospective cohort.

Several methods (dinoprostone, oxytocin, misoprostol, balloon catheter …) are used to induce labor in France. To decide and perform labor inductions, physicians can refer to published guidelines according to specific obstetrical situations. But many of these guidelines are based on a low level of evidence probably explaining observed differences in practices.

In some cases, labor induction is decided without indication, and women's involvement in this kind of decisions is not really evaluated.

The objectives are therefore :

* To evaluate the frequency of use of different methods for labor induction according to the cervix status, the indication of labor induction, and the place of the delivery.
* To analyse maternal, fetal and neonatal issues according to the different induction methods, taken into account the induction indications
* To compare current practices of labor induction to published national guidelines and to assess the impact of deviations from these guidelines on maternal and neonatal issues
* To assess women's satisfaction regarding the indication and the induction method used.

Conditions

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Induction of Labor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

all women with an induced labor

Intervention Type OTHER

all women who have an induced labor

Interventions

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all women with an induced labor

all women who have an induced labor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* in utero fetal death
* termination of pregnancy
* patient's refusal to participate to the study
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agence Nationale de sécurité du Médicament

OTHER

Sponsor Role collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille Le Ray

Role: PRINCIPAL_INVESTIGATOR

Assistance publique des Hôpitaux de Paris (APHP)

François Goffinet

Role: STUDY_DIRECTOR

Assistance publique des Hôpitaux de Paris (APHP)

Locations

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

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 31403585 (View on PubMed)

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.

Reference Type RESULT
PMID: 31628852 (View on PubMed)

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.

Reference Type RESULT
PMID: 29196154 (View on PubMed)

Other Identifiers

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AAP-2014-030

Identifier Type: -

Identifier Source: org_study_id

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