Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

Delivery, Obstetric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769792
• Other study ID #: 1/1/2018 (Sep 8)
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: March 2020
• Source: OASIS Diagnostics S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 23, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• after natural delivery and post-partum period (6-8 weeks after delivery)

• physiological pregnancy

• observed a perianal tear of grade 1-4 in the OASIS classification

• signed informed consent

Exclusion Criteria:

• presence of acute diseases during treatment

• presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension),

• presence of diseases, with symptoms of fecal incontinence,

• previous proctological operations,

• the presence of inflammatory bowel diseases in the stage of exacerbation,

• treatment in the last year due to severe, progressive, uncontrolled cardiac, pulmonary, nephrological, infectious or psychiatric disease, which course could affect the patient's risk due to participation in study,

• significant deviations from the norm in a physical examination during V0 visit or laboratory tests taken during the same visit,

• significant disease symptoms so far undiagnosed and reported during the V0 visit

• presence or suspected malignant disease or previous oncological treatment during the last 5 years,

• presence of a cardiac stimulator or cardioverter-defibrillator,

• severe surgery or severe trauma in the last year.

Related Conditions & MeSH terms

• Delivery, Obstetric
• Obstetric Anal Sphincter Injury
• Wounds and Injuries

Intervention

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
• Transanal ultrasonography
During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
• Anorectal manometry
During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Locations

Country	Name	City	State
Poland	Centrum Medyczne Byc Kobieta s.c.	Lódz	Lodzkie

Sponsors (1)

Lead Sponsor	Collaborator
OASIS Diagnostics S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal sphincters injury	Assessed by subsequent measures: Sphincter continuity in physical examination,; Sphincter tension in physical examination,; OASIS classification of perineal tears in transanal ultrasonography; Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference); Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters); anorectal manometry assessment to measure anal sphincters function; All measurements are used to estimate the presence, extent and severity of anal sphincter injury.; The main aim of the study is to establish whether the extension and severity of obstetric anal sphincter injury can be precisely assessed with parameters calculated from pelvic floor muscles using impedance spectroscopy.	8 weeks
Secondary	Adverse events	Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.	8 weeks

External Links

•   Sponsor's website