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

Обзор

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.

Вмешательства

• Диагностический тест 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
  Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and a rectal examination with machine learning-assisted electrical impedance spectroscopy within the first hour postpartum: the examination will be performed by a gynecologist or a midwife. If an obstetric anal sphincter injury (OASI) is considered as detected women will be managed in line with local practice for OASI. In case primary surgical repair is decided, it should be carried out within

Первичные конечные точки

• 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. [Срок оценки: From enrollment to the follow-up visit that will be performed within 12 weeks postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Active inflammatory bowel disease affecting the perianal area
• Implants in the pelvic area
• Major malformations in perianal area or anal prolapse

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07474012 · ON-ASY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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