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Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

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ClinicalTrials.gov Identifier: NCT03769792
Recruitment Status : Active, not recruiting
First Posted : December 10, 2018
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
OASIS Diagnostics S.A.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obstetric Anal Sphincter Injury Delivery, Obstetric 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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Arm Intervention/treatment
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 8 weeks ]
    Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769792


Locations
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Poland
Centrum Medyczne Byc Kobieta s.c.
Łódź, Lodzkie, Poland, 95-070
Sponsors and Collaborators
OASIS Diagnostics S.A.
Investigators
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Principal Investigator: Grzegorz Surkont, MD, PhD Centrum Medyczne Byc Kobieta s.c.
More Information
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Additional Information:
Sponsor's website  This link exits the ClinicalTrials.gov site

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Responsible Party: OASIS Diagnostics S.A.
ClinicalTrials.gov Identifier: NCT03769792     History of Changes
Other Study ID Numbers: 1/1/2018 (Sep 8)
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OASIS Diagnostics S.A.:
Obstetrical anal sphincter injury
Impedance spectroscopy
Additional relevant MeSH terms:
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Wounds and Injuries