Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- The investigator will evaluate the detection rate for OASI in primiparous women who have completed vaginal delivery comparing standard digital rectal digital rectal examination and machine learning-assisted electrical impedance spectroscopy.
研究概览
简要总结
The investigator will evaluate the detection rate for Obstetric Anal Sphincter Injuries (OASI) in primiparas having given vaginal childbirth, comparing the sensitivity of methods available in a labour ward setting for rapid detection: standard digital rectal examination (DRE) and Machine Learning-assisted electrical impedance spectroscopy (applied with the ONIRY system).
Endoanal Ultrasound (EAUS) is used as the reference standard for diagnosis' confirmation and performed within 12 weeks post-delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult, legally competent woman
- •Freely given written informed consent
- •Pregnant, primigravid, admitted to labour ward and planned for vaginal delivery
- •Woman in the early postpartum period (up to 1 hour postpartum) after the vaginal (spontaneous or assisted) childbirth, of a neonate of birth weight of at least 500 g or, if birth weight does not apply, gestational age of at least 22 completed weeks; if neither of the two applies, the neonate crown-heel length of at least 25cm
- •Absence of any contraindication for use of machine learning-assisted electrical impedance spectroscopy
- •Not currently participating or planned for any other research study related to obstetrics or proctology
排除标准
- •Active inflammatory bowel disease affecting the perianal area
- •Implants in the pelvic area
- •Major malformations in perianal area or anal prolapse
研究组 & 干预措施
Primigravid admitted to labour ward for vaginal delivery
干预措施: Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopy (Diagnostic Test)
结局指标
主要结局
The investigator will evaluate the detection rate for OASI in primiparous women who have completed vaginal delivery comparing standard digital rectal digital rectal examination and machine learning-assisted electrical impedance spectroscopy.
时间窗: From enrollment to the follow-up visit that will be performed within 12 weeks postpartum
次要结局
未报告次要终点
研究者
Stefano Salvatore
Professor
IRCCS San Raffaele