Induction of LaborMEDIPNCT02477085
Methods of Labor Induction and Perinatal Outcomes
An observational study of Induction of Labor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- all women with an induced labor
- How many people
- 3,049 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: all women who have an induced labor
Who may be able to join
- 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
Who cannot join
- in utero fetal death
- termination of pregnancy
- patient's refusal to participate to the study
Trial locations and contacts
1 site in 1 country.
France1 site
Port-Royal maternity unit, Cochin Hospital, Assistance publique des Hôpitaux de Paris (APHP
Paris, 75014
About this study
Official title: 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.
Read the 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.
- Conditions
- Induction of Labor
- Being tested
- all women with an induced labor
- Keywords
- Labor, induction, delivery, prostaglandins, oxytocin, amniotomy, balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all women with an induced laborOther
all women who have an induced labor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: all women with an induced labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Beginning of labor induction
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 8 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Camille Le Ray, Principal investigator, Assistance publique des Hôpitaux de Paris (APHP)François Goffinet, Study director, Assistance publique des Hôpitaux de Paris (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477085
- Sponsor's protocol ID
- AAP-2014-030
- Acronym
- MEDIP
- Status last verified
- Oct 2025
- First submitted
- 10 Jun 2015
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31403585Blanc-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.
PubMed 31628852Blanc-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.
PubMed 29196154
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods of Labor Induction and Perinatal Outcomes : a Prospective National Study in France
- ClinicalTrials.gov ID
- NCT02477085
- Acronym / sponsor ID
- MEDIP / AAP-2014-030
- Conditions
- Induction of Labor
- Keywords
- Labor, induction, delivery, prostaglandins, oxytocin, amniotomy, balloon catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,049 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament, URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all women with an induced labor | – | Other: all women with an induced laborprospective population-based cohort of all women who have an induced labor during one month in seven perinatal networks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all women who have an induced labor
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- in utero fetal death
- termination of pregnancy
- patient's refusal to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all women with an induced laborall women who have an induced labor | Other | all women with an induced labor |
Primary outcome
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
3 secondary outcomes
Composite measure of maternal morbidity
Time frame: Labor induction
Composite measure of fetal and neonatal mortality and morbidity
Time frame: from induction up to average 7 days post delivery
Women's satisfaction Questionnaire
Time frame: 8 weeks after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 31403585Jochum 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.
- Results publication: PubMed 31628852Blanc-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.
- Results publication: PubMed 29196154Blanc-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.
Related trials for Induction of Labor
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
RecruitingPhase 3
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Le Ray principal investigator
Assistance publique des Hôpitaux de Paris (APHP)
François Goffinet study director
Assistance publique des Hôpitaux de Paris (APHP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induction of Labor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of induction methods (time frame: Beginning of labor induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02477085, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.