Sphincter (Anal); Perineal Rupture, Obstetric
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTPrimiparous 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 12 hours postpartum. A follow-up visit will be performed within 12 weeks postpartum. During this visit endoanal ultrasound will be performed and anal continence evaluated using Wexner score.
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Active inflammatory bowel disease affecting the perianal area * Implants in the pelvic area * Major malformations in perianal area or anal prolapse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | From enrollment to the follow-up visit that will be performed within 12 weeks postpartum |
Contacts
CONTACTStefano Salvatore Prof.
PRINCIPAL_INVESTIGATORStefano Salvatore
IRCCS San Raffele
Outcome results
None listed