Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

September 15, 2020 updated by: OASIS Diagnostics S.A.

Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 05-077
        • Praktyka Lekarska Małgorzata Uchman-Musielak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
16 weeks
Anal sphincter tension (function) assessed in physical examination and anorectal manometry
Time Frame: 16 weeks
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 16 weeks
Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OASIS Diagnostics S.A.

Investigators

  • Principal Investigator: Małgorzata Uchman-Musielak, MD, PhD, Specialist Medical Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2019

Primary Completion (ACTUAL)

June 26, 2020

Study Completion (ACTUAL)

July 20, 2020

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (ACTUAL)

December 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/1/2019 (May 6)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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