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Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

Primary Purpose

Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Blood and faeces tests
Impedance spectroscopy test
Full gynecological and proctological examination
Transanal ultrasonography
Anorectal manometry
Determining the degree of sphincter injury
Sponsored by
OASIS Diagnostics S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstetric Anal Sphincter Injury focused on measuring Obstetric Anal Sphincter Injury, Impedance Spectroscopy

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Praktyka Lekarska Małgorzata Uchman-Musielak

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Impedance spectroscopy

Arm Description

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

Outcomes

Primary Outcome Measures

Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography
Assessment using: OASIS classification of perineal tears. Starck scale (0-16 scale, no defect - 0, maximum - 16, which means severe damage of both sphincters on a considerable length and circumference). 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
Anal sphincter assessment evaluated by impedance spectroscopy
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

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

Full Information

First Posted
November 21, 2019
Last Updated
September 15, 2020
Sponsor
OASIS Diagnostics S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04181840
Brief Title
Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
Official Title
Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OASIS Diagnostics S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
Keywords
Obstetric Anal Sphincter Injury, Impedance Spectroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impedance spectroscopy
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood and faeces tests
Intervention Description
During V1 - Laboratory tests, particularly for calprotectin concentration assessment
Intervention Type
Device
Intervention Name(s)
Impedance spectroscopy test
Intervention Description
During V1 - the electrical impedance of anal sphincter muscles will be measured
Intervention Type
Diagnostic Test
Intervention Name(s)
Full gynecological and proctological examination
Intervention Description
During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
Transanal ultrasonography
Intervention Description
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Intervention Type
Diagnostic Test
Intervention Name(s)
Anorectal manometry
Intervention Description
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Intervention Type
Other
Intervention Name(s)
Determining the degree of sphincter injury
Intervention Description
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 Measure Information:
Title
Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography
Description
Assessment using: OASIS classification of perineal tears. Starck scale (0-16 scale, no defect - 0, maximum - 16, which means severe damage of both sphincters on a considerable length and circumference). Norderval scale (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters).
Time Frame
16 weeks
Title
Anal sphincter tension (function) assessed in physical examination and anorectal manometry
Time Frame
16 weeks
Title
Anal sphincter assessment evaluated by impedance spectroscopy
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women patients, 18-49 years old, up to 16 weeks from a natural delivery with the presence of: clinically confirmed OASIS at least stage II, as a result of an episiotomy or uncontrolled crotch rupture (in patients with crotch protection), or 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Uchman-Musielak, MD, PhD
Organizational Affiliation
Specialist Medical Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Praktyka Lekarska Małgorzata Uchman-Musielak
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
05-077
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.oasis-diagnostics.eu
Description
Sponsor's website

Learn more about this trial

Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

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