Methods of Labor Induction and Perinatal Outcomes (MEDIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labor
• Intervention / Treatment: 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
• Enrollment (Actual): 3049

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

all women who have an induced labor

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin; 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)

Publications and helpful links

General Publications

• Jochum F, Le Ray C, Blanc-Petitjean P, Langer B, Meyer N, Severac F, Sananes N. Externally Validated Score to Predict Cesarean Delivery After Labor Induction With Cervi Ripening. Obstet Gynecol. 2019 Sep;134(3):502-510. doi: 10.1097/AOG.0000000000003405.
• Blanc-Petitjean P, Schmitz T, Salome M, Goffinet F, Le Ray C; MEDIP Study Group. Target populations to reduce cesarean rates after induced labor: A national population-based cohort study. Acta Obstet Gynecol Scand. 2020 Mar;99(3):406-412. doi: 10.1111/aogs.13751. Epub 2019 Nov 19.
• Blanc-Petitjean P, Salome M, Dupont C, Crenn-Hebert C, Gaudineau A, Perrotte F, Raynal P, Clouqueur E, Beucher G, Carbonne B, Goffinet F, Le Ray C. Labour induction practices in France: A population-based declarative survey in 94 maternity units. J Gynecol Obstet Hum Reprod. 2018 Feb;47(2):57-62. doi: 10.1016/j.jogoh.2017.11.006. Epub 2017 Nov 28.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimated): June 22, 2015

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: oxytocin; delivery; Labor; balloon catheter; induction; prostaglandins; amniotomy
• Other Study ID Numbers: AAP-2014-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No