跳至主要内容
临床试验/NCT07314970
NCT07314970招募中不适用

Impact of the Practitioner's Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Overall satisfaction of women who gave birth to a breech fetus regarding their medical care

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Up to 12 months

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

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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