NCT01320995终止不适用
Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2011年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 111
- 试验地点
- 4
- 主要终点
- Presence/absence of anal incontinence
研究概览
简要总结
The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 3 months of follow up
- •The patient is delivering her first child; vaginal delivery
- •The patient has a minimum stage 2 perineal lesion
- •The patient accepts perineal echography
排除标准
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Cesarien section
- •No perineal lesion (intact perineum)
- •Emergency situation which hinders screening for anal lesions under good medical conditions
- •Previous vaginal delivery
研究组 & 干预措施
Experimental arm
Experimental
In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.
干预措施: Perineal ultrasound (Procedure)
Standard arm
No Intervention
No perineal ultrasound immediately after delivery.
结局指标
主要结局
Presence/absence of anal incontinence
时间窗: 3 months
Anal incontinence is defined as a Wexner score \> 4
次要结局
- Wexner anal incontinence score(3 months)
- Visual Analog Scale for discomfort during perineal ultrasound(2 hours)
- Kappa coefficient for second reading of ultrasounds(30 days)
- Presence/absence of a sphincter tear(2 hours)
- Patient requires anal sutures (yes/no)(2 hours)
- Presence/absence of suture infection(3 months)
- Questionnaire PFIQ(3 months)
- Questionnaire PFDI(3 months)
- Questionnaire SF36(3 months)
- Questionnaire Euroqol(3 months)
研究者
研究点 (4)
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