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Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

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ClinicalTrials.gov Identifier: NCT04181840
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
OASIS Diagnostics S.A.

Brief Summary:

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises up to 56 patients; up to 16 weeks from a natural delivery. The planned participation of each patient in the study is up to 4 weeks and two visits will take place at that time.

After obtaining written consent, at the first visit (V1) each patient will undergo a physical examination (both proctological and gynecological examination), blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. The presence of clinical symptoms of both gas and stool incontinence will be assessed during the visit with the use of Wexner's scale. Then, the dates of two reference tests will be planned: Trans-rectal USG and Recto-anal manometry which will be performed as part of the V1 visit within a period not exceeding 27 days.

The V2 visit, which will also be the final visit, will include a reassessment of the patient's general condition, recording the values of basic vital parameters, subjective and physical examination, and then the doctor conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.

During the visits, all adverse events will also be monitored, both those reported by patients and those related to the examined diagnostic device.


Condition or disease Intervention/treatment Phase
Obstetric Anal Sphincter Injury Delivery Complication Obstetric Complication 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 Other: Determining the degree of sphincter injury Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Impedance spectroscopy

Maximum 56 women up to 16 weeks from a natural delivery, with at least one perinatal anal sphincter injury risk factor, such as: the extended second delivery phase, instrumental delivery (vacuum or forceps), shoulder dystocia, birth weight of the child > 4kg, episiotomy, uncontrolled perineal laceration (in patients with crotch protection).

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 V1 - Laboratory tests, particularly for calprotectin concentration assessment

Device: Impedance spectroscopy test
During V1 - the electrical impedance of anal sphincter muscles will be measured

Diagnostic Test: Full gynecological and proctological examination
During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy

Diagnostic Test: Transanal ultrasonography
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Diagnostic Test: Anorectal manometry
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Other: Determining the degree of sphincter injury
During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.




Primary Outcome Measures :
  1. Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography [ Time Frame: 16 weeks ]

    Assessment using:

    1. OASIS classification of perineal tears.
    2. Starck scale (0-16 scale, no defect - 0, maximum - 16, which means severe damage of both sphincters on a considerable length and circumference).
    3. Norderval scale (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters).

  2. Anal sphincter tension (function) assessed in physical examination and anorectal manometry [ Time Frame: 16 weeks ]
  3. Anal sphincter assessment evaluated by impedance spectroscopy [ Time Frame: 16 weeks ]

    Estimation of the presence, extent and severity of anal sphincter injury, by impedance moduli and phase shifts.

    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 anal sphincter muscles using impedance spectroscopy.



Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 16 weeks ]
    Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.



Information from the National Library of Medicine

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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:

  • women patients,
  • 18-49 years old,
  • up to 16 weeks from a natural delivery
  • with the presence of:

    1. clinically confirmed OASIS at least stage II, as a result of an episiotomy or uncontrolled crotch rupture (in patients with crotch protection), or
    2. at least one risk factor, such as:
  • the extended second delivery phase,
  • instrumental delivery (vacuum or forceps),
  • shoulder dystocia,
  • birth weight of the child > 4kg,
  • episiotomy,
  • uncontrolled perineal laceration (in patients with crotch protection),
  • induction of delivery using oxytocin,
  • head circumference ≥34 mm and other.
  • the patient's understanding of the nature of the clinical study and permission in writing from the patient to participate in this study.

Exclusion Criteria:

  • the presence of acute diseases during treatment,
  • the presence of chronic diseases not treated or treated insufficiently (e.g., incorrectly controlled hypertension),
  • the presence of diseases with accompanying symptoms of fecal incontinence history of proctology surgery's whit postoperative complication,
  • the presence of inflammatory bowel diseases during the exacerbation phase,
  • the treatment in the last year because of serious, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness whose course could affect the patient's risk increase due to participation in the study,
  • significant disease symptoms so far undiagnosed,
  • the presence or suspected malignant disease or previous on previous oncological treatment in the last 5 years,
  • the presence of a cardiac stimulator or cardioverter-defibrillator,
  • severe surgery or severe trauma in the last year.

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): NCT04181840


Contacts
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Contact: Katarzyna Borycka-Kiciak, MD, PhD +48 664 454 040 katarzyna.borycka@oasis-diagnostics.eu

Locations
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Poland
Praktyka Lekarska Małgorzata Uchman-Musielak Recruiting
Warsaw, Mazowieckie, Poland, 05-077
Contact: Małgorzata Uchman-Musielak, MD, PhD         
Principal Investigator: Małgorzata Uchman-Musielak, MD, PhD         
Sponsors and Collaborators
OASIS Diagnostics S.A.
Investigators
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Principal Investigator: Małgorzata Uchman-Musielak, MD, PhD Specialist Medical Practice

Additional Information:
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Responsible Party: OASIS Diagnostics S.A.
ClinicalTrials.gov Identifier: NCT04181840     History of Changes
Other Study ID Numbers: 2/1/2019 (May 6)
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 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.:
Obstetric Anal Sphincter Injury
Impedance Spectroscopy
Additional relevant MeSH terms:
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Wounds and Injuries