Methods of Labor Induction and Perinatal Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France

Conditions
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Induction of Labor

Intervention / Treatment
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* Other: all women with an induced labor


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all women with an induced labor<br>prospective population-based cohort of all women who have an induced labor during one month in seven perinatal networks | Other: all women with an induced labor<br>* all women who have an induced labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delivery, oxytocin, Labor, induction, prostaglandins, amniotomy, balloon catheter