Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 4, 2019

Primary Completion Date

October 30, 2019

Study Completion Date

December 23, 2019

Conditions
Obstetric Anal Sphincter InjuryDelivery, Obstetric
Interventions
DIAGNOSTIC_TEST

Blood and faeces tests

During V0 - Laboratory tests, particularly for calprotectin concentration assessment

DEVICE

Impedance spectroscopy test

During V1 - the electrical impedance of pelvic floor muscles will be measured

DIAGNOSTIC_TEST

Full gynecological and proctological examination

During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy

DIAGNOSTIC_TEST

Transanal ultrasonography

During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

DIAGNOSTIC_TEST

Anorectal manometry

During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Trial Locations (1)

95-070

Centrum Medyczne Byc Kobieta s.c., Lodz

Sponsors
All Listed Sponsors
lead

OASIS Diagnostics S.A.

INDUSTRY