Clinical trial NCT02477085: Methods of Labor Induction and Perinatal Outcomes
Official title: Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labor
Keywords: Labor
induction
delivery
prostaglandins
oxytocin
amniotomy
balloon catheter
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Nationale de sécurité du Médicament
First posted: 2015-06-22
Enrollment: 3049
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all women who have an induced labor

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite measure of induction methods
timeFrame: Beginning of labor induction
Secondary outcomes:
measure: Composite measure of maternal morbidity
timeFrame: Labor induction
measure: Composite measure of fetal and neonatal mortality and morbidity
timeFrame: from induction up to average 7 days post delivery
measure: Women's satisfaction Questionnaire
timeFrame: 8 weeks after delivery
Other outcomes:
Locations:
city: Paris
country: France
facility: Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP
Study officials:
affiliation: Assistance publique des Hôpitaux de Paris (APHP)
name: Camille Le Ray
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance publique des Hôpitaux de Paris (APHP)
name: François Goffinet
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.