Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 2
- 主要终点
- The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.
研究概览
简要总结
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section. So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.
详细描述
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.
So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective. It seems to be very useful to compare, in randomized controlled study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).
The primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. The investigators estimated, needing 123 women in each arm.
Hospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •More than 18 years old
- •Having health insurance
- •Second pregnancy
- •Inclusion in the third trimester
- •First delivery was traumatic
- •No anal incontinence
- •Accept to participate, sign the informed consent
- •Prior medical examination
排除标准
- •Monitoring impossible
- •Woman who have an anal operation
- •Caesarean section
- •First delivery with anal break stage 4
- •Indication of a scheduled caesarean section not for proctologic reason
- •Patient physically, mentally or legally incompetent to give informed consent
结局指标
主要结局
The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.
时间窗: 6 months
次要结局
- Incontinence scores in the two arms after 6/8 weeks and 6 month, transitional anal incontinence after delivery urinary incontinence 6 and 12 month after the delivery, sexual score(IFSI)global morbidity between the two arms after anal endoscopy(6 month and 12 month)