Methods of Labor Induction and Perinatal Outcomes

Overview

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.

Full Title of Study: “Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2016

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

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

Arms, Groups and Cohorts

  • all women with an induced labor
    • prospective population-based cohort of all women who have an induced labor during one month in seven perinatal networks

Clinical Trial Outcome Measures

Primary Measures

  • Composite measure of induction methods
    • Time Frame: 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 Measures

  • Composite measure of maternal morbidity
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Agence Nationale de sécurité du Médicament
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Camille Le Ray, Principal Investigator, Assistance publique des Hôpitaux de Paris (APHP)
    • François Goffinet, Study Director, Assistance publique des Hôpitaux de Paris (APHP)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.