Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

NCT04181840 | Completed

• 1 other identifier: 2/1/2019 (May 6)
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Anal Sphincter Injury; Delivery Complication; Obstetric Complication

Keywords

Obstetric Anal Sphincter Injury; Impedance Spectroscopy

Outcome Measures

Primary Outcomes (3)

• Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography

  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

  16 weeks

• 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.

  16 weeks

Secondary Outcomes (1)

• Adverse events

  16 weeks

Study Arms (1)

Impedance spectroscopy

EXPERIMENTAL

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; 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

Interventions

Blood and faeces tests DIAGNOSTIC_TEST

During V1 - Laboratory tests, particularly for calprotectin concentration assessment

Impedance spectroscopy

Impedance spectroscopy test DEVICE

During V1 - the electrical impedance of anal sphincter muscles will be measured

Impedance spectroscopy

Full gynecological and proctological examination DIAGNOSTIC_TEST

During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy

Impedance spectroscopy

Transanal ultrasonography DIAGNOSTIC_TEST

During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Impedance spectroscopy

Anorectal manometry DIAGNOSTIC_TEST

During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Impedance spectroscopy

Determining the degree of sphincter injury OTHER

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.

Impedance spectroscopy

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women patients,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OASIS Diagnostics S.A.: lead

Study Sites (1)

Praktyka Lekarska Małgorzata Uchman-Musielak

Warsaw, Masovian Voivodeship, 05-077, Poland

Location

Related Links

• Sponsor's website

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Małgorzata Uchman-Musielak, MD, PhD

  Specialist Medical Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 2, 2019
• Study Start: October 15, 2019
• Primary Completion: June 26, 2020
• Study Completion: July 20, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)