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Methods of Labor Induction and Perinatal Outcomes (MEDIP)

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ClinicalTrials.gov Identifier: NCT02477085
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Agence Nationale de sécurité du Médicament
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Induction of Labor Other: all women with an induced labor

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.

Study Type : Observational
Actual Enrollment : 3049 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France
Study Start Date : November 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
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
Other: all women with an induced labor
all women who have an induced labor




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all women who have an induced labor
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477085


Locations
France
Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Agence Nationale de sécurité du Médicament
Investigators
Principal Investigator: Camille Le Ray Assistance publique des Hôpitaux de Paris (APHP)
Study Director: François Goffinet Assistance publique des Hôpitaux de Paris (APHP)

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02477085     History of Changes
Other Study ID Numbers: AAP-2014-030
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Labor
induction
delivery
prostaglandins
oxytocin
amniotomy
balloon catheter