NCT07314970

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 17, 2025

Last Update Submit

December 31, 2025

Conditions

Keywords

Breech Presentation

Outcome Measures

Primary Outcomes (1)

  • Overall satisfaction of women who gave birth to a breech fetus regarding their medical care

    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

Study Arms (2)

Doctor 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.

Other: To complete a questionnaire

Adult woman (≥ 18 years old)

* Gave birth in 2024 at a university hospital in the Grand Est region (Besançon, Reims, Strasbourg, Nancy) * Breech delivery \> 37 weeks gestation * Agree to complete the self-administered questionnaire anonymously.

Other: To complete a questionnaire

Interventions

Doctor and Adult woman agreeing to complete the self-administered questionnaire anonymously.

Adult woman (≥ 18 years old)Doctor with a primary focus on Obstetrics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 2, 2026

Study Start

January 28, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations