Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE November 21, 2019
First Posted Date  ICMJE December 2, 2019
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • 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).
  • Anal sphincter tension (function) assessed in physical examination and anorectal manometry [ Time Frame: 16 weeks ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
Adverse events [ Time Frame: 16 weeks ]
Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
Official Title  ICMJE Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Obstetric Anal Sphincter Injury
  • Delivery Complication
  • Obstetric Complication
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
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
  • Other: Determining the degree of sphincter injury
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2019)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katarzyna Borycka-Kiciak, MD, PhD +48 664 454 040 katarzyna.borycka@oasis-diagnostics.eu
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181840
Other Study ID Numbers  ICMJE 2/1/2019 (May 6)
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  ICMJE
Plan to Share IPD: No
Responsible Party OASIS Diagnostics S.A.
Study Sponsor  ICMJE OASIS Diagnostics S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Małgorzata Uchman-Musielak, MD, PhD Specialist Medical Practice
PRS Account OASIS Diagnostics S.A.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP