NCT03769792

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

October 9, 2018

Last Update Submit

March 3, 2020

Conditions

Obstetric Anal Sphincter InjuryDelivery, Obstetric

Keywords

Obstetrical anal sphincter injuryImpedance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Anal sphincters injury

    Assessed by subsequent measures: 1. Sphincter continuity in physical examination, 2. Sphincter tension in physical examination, 3. OASIS classification of perineal tears in transanal ultrasonography 4. 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) 5. 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) 6. 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.

    8 weeks

Secondary Outcomes (1)

  • Adverse events

    8 weeks

Study Arms (1)

Impedance spectroscopy

EXPERIMENTAL

24 women will be included in the study and divided into two subgroups. 12 of them (first subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 1 or 2 in OASIS classification. Remaining 12 (second subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 3 or 4 in OASIS classification. 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 testsDevice: Impedance spectroscopy testDiagnostic Test: Full gynecological and proctological examinationDiagnostic Test: Transanal ultrasonographyDiagnostic Test: Anorectal manometry

Interventions

Blood and faeces testsDIAGNOSTIC_TEST

During V0 - Laboratory tests, particularly for calprotectin concentration assessment

Impedance spectroscopy
Impedance spectroscopy testDEVICE

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

Impedance spectroscopy
Full gynecological and proctological examinationDIAGNOSTIC_TEST

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

Impedance spectroscopy
Transanal ultrasonographyDIAGNOSTIC_TEST

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

Impedance spectroscopy
Anorectal manometryDIAGNOSTIC_TEST

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

Impedance spectroscopy

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Medyczne Byc Kobieta s.c.

Lodz, Łódź Voivodeship, 95-070, Poland

Location

Related Links

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Grzegorz Surkont, MD, PhD

    Centrum Medyczne Byc Kobieta s.c.

    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

October 9, 2018

First Posted

December 10, 2018

Study Start

February 4, 2019

Primary Completion

October 30, 2019

Study Completion

December 23, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)