Induction of Labor
Conditions
Keywords
Labor, induction, delivery, prostaglandins, oxytocin, amniotomy, balloon catheter
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.
Interventions
OTHERall women with an induced labor
all women who have an induced labor
Sponsors
Agence Nationale de sécurité du Médicament
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite measure of induction methods | Beginning of labor induction | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite measure of maternal morbidity | Labor induction | * 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 |
| Composite measure of fetal and neonatal mortality and morbidity | from induction up to average 7 days post delivery | * 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 |
| Women's satisfaction Questionnaire | 8 weeks after delivery | 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 |
Countries
France
Outcome results
None listed