Methods of Labor Induction and Perinatal Outcomes

Induction of Labor Clinical Trial

— MEDIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477085
• Other study ID #: AAP-2014-030
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Induction of Labor

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