Ignite Creation Date:
2025-12-18 @ 8:38 AM
Ignite Modification Date:
2025-12-23 @ 10:01 PM
Study NCT ID:
NCT02477085
Status:
None
Last Update Posted:
2025-11-20 00:00:00
First Post:
2015-06-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methods of Labor Induction and Perinatal Outcomes
Sponsor:
None
Organization:
Study Overview
Official Title:
Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France
Status:
None
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDIP
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: