Verifying Anal Sphincter Integrity in the Delivery Room Using a Specific Perineal Ultrasound: Impact on Immediate Care and Postpartum Anal Incontinence Rates in Mothers Undergoing Vaginal Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 6
- 主要终点
- Presence/absence of an anal sphincter rupture
研究概览
简要总结
The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. This study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.
详细描述
The secondary objectives of this study are:
A. Compare the anal incontinence score (measured by the Wexner score, qualitative and quantitative assessment) at 3 months between the two groups.
B. To assess the safety of perineal ultrasound in the group with "ultrasound" using a visual analog scale for discomfort
C. Assess the inter and intra operator consistency of perineal ultrasound snapshot readings
D. Evaluate and compare the rate of infectious complications of perineal sutures between the two groups at 3 months.
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
- •The patient must have given 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
- •Paturient, vaginal births only
- •Presence of >= stage 2 perineal lesion
- •Patient accepts a priori the performance of a perineal ultrasound
排除标准
- •The patient is participating in another study (excepting BBBOX (2011-A00327-36), ElastoMAP (2013-A01148-37), ElastoDéclench, BAKRI, Papillo PMA, GrossPath, LXRs, DGPostPartum, "scalp lactates", and UpSideDown studies)
- •The patient is in an exclusion period determined by a previous study
- •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
- •Delivery by C-section
- •Intact perineum after delivery (no indication for perineal surgery in light of absence of vaginal lesion)
- •Emergency situation preventing time for perineal ultrasound
- •History of anal incontinence before giving birth
- •Allergy to ultrasound gel
结局指标
主要结局
Presence/absence of an anal sphincter rupture
时间窗: Day 0
次要结局
- PFIQ questionnaire(3 months)
- PFDI questionnaire(3 months)
- Presence/absence of suture infection(3 months)
- Wexner score for anal incontinence(3 months)
- Tolerance of perineal ultrasound(Day 0)
- Kappa coefficient for inter-operator ultrasound reading(Day 0)
- Kappa coefficient for intra-operator ultrasound reading(Day 0)
- SF36 questionnaire(3 months)
- Euroqol questionnaire(3 months)