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NCT Number: NCT02477085

Methods of Labor Induction and Perinatal Outcomes

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.

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Key information

Conditions

Induction of Labor

Sex eligibility

Female

Study type

Observational

Primary location

Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

all women with an induced labor

Other

all women who have an induced labor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Agence Nationale de sécurité du Médicament
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: MEDIP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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