Overview

This trial is active, not recruiting.

Condition induction of labor
Treatment all women with an induced labor
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Agence Nationale de sécurité du Médicament
Start date November 2015
End date May 2016
Trial size 3100 participants
Trial identifier NCT02477085, AAP-2014-030

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
all women who have an induced labor

Primary Outcomes

Measure
Composite measure of induction methods
time frame: Beginning of labor induction

Secondary Outcomes

Measure
Composite measure of maternal morbidity
time frame: Labor induction
Composite measure of fetal and neonatal mortality and morbidity
time frame: from induction up to average 7 days post delivery
Women's satisfaction Questionnaire
time frame: 8 weeks after delivery

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France
Principal investigator Camille Le Ray
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.