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NCT Number: NCT03769792

Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time.

After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected.

On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out.

On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.

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Key information

Conditions

Obstetric Anal Sphincter Injury Delivery, Obstetric

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centrum Medyczne Byc Kobieta s.c.

Lodz, Łódź Voivodeship, 95-070, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • after natural delivery and post-partum period (6-8 weeks after delivery)
  • physiological pregnancy
  • observed a perianal tear of grade 1-4 in the OASIS classification
  • signed informed consent

Exclusion criteria

  • presence of acute diseases during treatment
  • presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension),
  • presence of diseases, with symptoms of fecal incontinence,
  • previous proctological operations,
  • the presence of inflammatory bowel diseases in the stage of exacerbation,
  • treatment in the last year due to severe, progressive, uncontrolled cardiac, pulmonary, nephrological, infectious or psychiatric disease, which course could affect the patient's risk due to participation in study,
  • significant deviations from the norm in a physical examination during V0 visit or laboratory tests taken during the same visit,
  • significant disease symptoms so far undiagnosed and reported during the V0 visit
  • presence or suspected malignant disease or previous oncological treatment during the last 5 years,
  • presence of a cardiac stimulator or cardioverter-defibrillator,
  • severe surgery or severe trauma in the last year.

Treatment and study plan

Blood and faeces tests

Diagnostic Test

During V0 - Laboratory tests, particularly for calprotectin concentration assessment

Impedance spectroscopy test

Device

During V1 - the electrical impedance of pelvic floor muscles will be measured

Full gynecological and proctological examination

Diagnostic Test

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

Transanal ultrasonography

Diagnostic Test

During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Anorectal manometry

Diagnostic Test

During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Primary outcomes

  1. Anal sphincters injury

    Time frame: 8 weeks

    Assessed by subsequent measures:

    • Sphincter continuity in physical examination,
    • Sphincter tension in physical examination,
    • OASIS classification of perineal tears in transanal ultrasonography
    • Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference)
    • Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters)
    • anorectal manometry assessment to measure anal sphincters function

    All measurements are used to estimate the presence, extent and severity of anal sphincter injury.

    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 pelvic floor muscles using impedance spectroscopy.

Secondary outcomes

  1. Adverse events

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

OASIS Diagnostics S.A.

Industry

Registry information

Official study title

Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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