- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314970
Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation (DISCOURS-SIEGE)
Impact of the Practitioner's Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation
Breech presentation is a common occurrence in routine practice, occurring in 3-4% of all term pregnancies. Despite its frequency, breech presentation at term remains a subject of considerable controversy within the medical community. This results in differing management approaches depending on the country, the center, and the practitioner. Indeed, from a pathophysiological perspective, during a breech delivery, the fetal head is the last segment to descend into the maternal pelvis. This is the largest fetal segment in terms of volume. Furthermore, the fetal head cannot accommodate itself to the maternal pelvis through plastic deformation. This presentation can therefore lead to specific complications that may be life-threatening for the unborn child.
Despite its frequency, breech presentation at term remains a subject of considerable controversy within the medical community regarding the management of labor. In the 2000s, a randomized trial called the TERM BREECH TRIAL found a neonatal benefit of planned cesarean section compared to vaginal delivery of a breech fetus (prevention of perinatal death in 1% of cases). This resulted in a significant increase in the rate of planned cesarean sections for breech presentation worldwide. However, numerous more recent studies (notably PREMODA in France) have highlighted the many biases of the Term Breech Trial, and various literature reviews (including the 2015 Cochrane review) have demonstrated lower perinatal morbidity than that found by Hannah's team. In 2020, the CNGOF (National College of Gynecologists and Obstetricians of France) published new recommendations on the management of breech presentations at the end of pregnancy, proposing vaginal delivery as a possible alternative to a planned cesarean section, provided that the patient receives clear and honest information (benefits and risks of each delivery method). The choice of delivery method must be made in consultation with the patient after a dedicated consultation. Since these recommendations were published, management practices still vary between hospitals despite fairly precise guidelines.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mary PONTVIANNE, MD
- Phone Number: 33 3 88 12 75 07
- Email: mary.pontvianne@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France
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Contact:
- Mary PONTVIANNE, MD
- Phone Number: 33 3 88 12 75 07
- Email: mary.pontvianne@chru-strasbourg.fr
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Principal Investigator:
- Mary PONTVIANNE, MD
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Principal Investigator:
- Joséphine GRIVEL, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Doctor with a medical degree (Junior Doctor, Clinical Assistant, Hospital Practitioner, University Professor of Obstetrics), with a primary focus on Obstetrics.
- Patient of legal age (≥ 18 years)
- Having given birth in 2024 in a university hospital in the Grand-Est region (Besançon, Reims, Strasbourg, Nancy)
Description
Inclusion Criteria:
Regarding practitioners:
- Doctor with a medical degree (Junior Doctor, Clinical Assistant, Hospital Practitioner, University Professor of Obstetrics), with a primary focus on Obstetrics
- Practicing in a University Hospital in the Grand Est region (Besançon, Reims, Strasbourg, Nancy)
- Agreeing to complete the self-administered questionnaire anonymously.
Regarding patients:
- Patient of legal age (≥ 18 years)
- Having given birth in 2024 in a university hospital in the Grand-Est region (Besançon, Reims, Strasbourg, Nancy)
- Delivery of a breech fetus > 37 weeks of gestation
- Agreeing to answer the self-administered questionnaire anonymously.
Exclusion Criteria:
Regarding practitioners:
Other primary activity than obstetrics
Regarding patients:
- Minor patient at the time of delivery
- Patient who had a cesarean section due to a uterine scar and maternal desire.
- Patients with a history of uterine scarring or the presence of obstruction previa were also excluded due to the impossibility of authorizing vaginal delivery, regardless of fetal presentation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Doctor with a primary focus on Obstetrics
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Doctor and Adult woman agreeing to complete the self-administered questionnaire anonymously.
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Adult woman (≥ 18 years old)
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Doctor and Adult woman agreeing to complete the self-administered questionnaire anonymously.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall satisfaction of women who gave birth to a breech fetus regarding their medical care
Time Frame: Up to 12 months
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Questionnaire from the book "The Joyful and Relaxed Pregnancy Guide" Score from 0 to 10: 0 = Not at all satisfied 5 = Partially satisfied 10 = Completely satisfied |
Up to 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9537
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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