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临床试验/NCT07084766
NCT07084766已完成不适用

The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

研究概览

简要总结

Intrauterine devices (IUDs) account for approximately 25% of contraceptive methods used in France. However, their insertion can be painful for patients and challenging for practitioners, particularly due to the passage through the cervix and the uterine flexion angle. An interventional study conducted by Cameron in 2013 examined the impact of bladder filling on the ease of IUD insertion. The results did not show a significant benefit, suggesting that a full bladder does not necessarily improve the procedure. An ongoing study, FLEXIMIX, led by the coordinator, explores the variation in the uterine flexion angle based on bladder filling in 250 nulliparous women. Preliminary results indicate a strong influence of bladder filling on the flexion angle. Additionally, the Valsalva maneuver, which involves increasing intra-abdominal pressure by forceful exhalation against a closed glottis, has been shown in two recent studies to facilitate gynecological interventions by improving cervical passage, thereby reducing the need for invasive instruments such as the tenaculum.What happens in parous women and during the Valsalva maneuver remains to be explored.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Adult women
  • •Experiencing the need to urinate
  • •Affiliated with a social security scheme or equivalent

排除标准

  • •Pregnant women
  • •Desire for pregnancy with ongoing conception process
  • •Age > 65 years
  • •History of hysterectomy
  • •History of conization
  • •Childbirth < 6 months
  • •Irrepressible need to urinate
  • •Inability or refusal to participate in the study

研究组 & 干预措施

Transabdominal ultrasonography

Other

Ultrasound measurements before and after bladder emptying

干预措施: ultrasonography, pelvic (Procedure)

结局指标

主要结局

Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

时间窗: 1 day

To determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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