Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

• ClinicalTrials.gov Identifier: NCT03769792
• Recruitment Status: Completed
• First Posted: December 10, 2018
• Last Update Posted: March 4, 2020
• Sponsor: OASIS Diagnostics S.A.
• Information provided by (Responsible Party): OASIS Diagnostics S.A.

Tracking Information

• First Submitted Date: October 9, 2018
• First Posted Date: December 10, 2018
• Last Update Posted Date: March 4, 2020
• Actual Study Start Date: February 4, 2019
• Actual Primary Completion Date: October 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2018)

Anal sphincters injury [ Time Frame: 8 weeks ]

Assessed by subsequent measures:

1. Sphincter continuity in physical examination,
2. Sphincter tension in physical examination,
3. OASIS classification of perineal tears in transanal ultrasonography
4. 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)
5. 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)
6. 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 5, 2018)

Adverse events [ Time Frame: 8 weeks ]

Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
• Official Title: Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Obstetric Anal Sphincter Injury
• Delivery, Obstetric

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
• 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.

Study Arms

Experimental: Impedance spectroscopy

24 women will be included in the study and divided into two subgroups.

12 of them (first subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 1 or 2 in OASIS classification.

Remaining 12 (second subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 3 or 4 in OASIS classification.

The planned interventions are:

• Blood and faeces tests
• Impedance spectroscopy test
• Full gynecological and proctological examination
• Transanal ultrasonography
• Anorectal manometry

Interventions:

• Diagnostic Test: Blood and faeces tests
• Device: Impedance spectroscopy test
• Diagnostic Test: Full gynecological and proctological examination
• Diagnostic Test: Transanal ultrasonography
• Diagnostic Test: Anorectal manometry

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 21, 2019): 20
• Original Estimated Enrollment (submitted: December 5, 2018): 24
• Actual Study Completion Date: December 23, 2019
• Actual Primary Completion Date: October 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT03769792
• Other Study ID Numbers: 1/1/2018 (Sep 8)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: OASIS Diagnostics S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: OASIS Diagnostics S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Grzegorz Surkont, MD, PhD; Centrum Medyczne Byc Kobieta s.c.

• PRS Account: OASIS Diagnostics S.A.
• Verification Date: March 2020