NCT03769792

Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: OASIS Diagnostics S.A. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time. After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out. On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.

Conditions

• Obstetric Anal Sphincter Injury
• Delivery, Obstetric

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-10-30
• Completion: 2019-12-23
• First posted: 2018-12-10
• Last updated: 2020-03-04

Locations

1 site across 1 country: Poland