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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02477085
Other study ID # AAP-2014-030
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date December 2016

Study information

Verified date July 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3049
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
all women with an induced labor
all women who have an induced labor

Locations

Country Name City State
France Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Agence Nationale de sécurité du Médicament

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Composite measure of maternal morbidity Systemic infection
Uterine hyperkinesia
Uterine hypertonia
Instrumental delivery
Caesarean section
Degrees of perineal lacerations
Surgical complications
Uterine rupture
Manual removal of the placenta
Postpartum haemorrhage
Anaemia
Maternal transfer in ICU
Labor induction
Secondary Composite measure of fetal and neonatal mortality and morbidity Fetal heart rate anomalies during labor
Apgar score
Acidosis (pH < 7.10)
Intubation
Surfactant treatment administration
Non-invasive ventilation
Cardiopulmonary resuscitation
Adrenaline administration
Neonatal mortality
Neonatal trauma (fracture of long bones or skull, brachial plexus elongation, injury of the spinal cord, subdural hematoma)
Neonatal transfer in ICU
from induction up to average 7 days post delivery
Secondary Women's satisfaction Questionnaire 18 questions about :
Woman's implication in the decision of labor induction
Woman's comprehension about the reason of labor induction
Woman's satisfaction about the decision/labor/delivery
8 weeks after delivery
See also
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