NCT04903977

Brief Summary

The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries. The study group comprises 150 primiparous or multiparous women up to 8 weeks after the vaginal (spontaneous or assisted) delivery of singleton, live foetus, in any presentation, in gestational week 34 or more. The timeline for each subject in the study will be up to 5 weeks and will include 3 visits (V1-V3). All participants will be divided into 3 groups: A, B, C. Group A - subjects with no perineal tear signs, Group B - subjects with grade 1 or 2 per OASIS classification, and Group C - subjects with grade 3 or 4). The diagnostic performance will be evaluated in comparison to 3-D EUS (endoanal ultrasound) as a primary performance measure (primary endpoint).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
4 countries

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

May 17, 2021

Last Update Submit

January 19, 2024

Conditions

Obstetric Anal Sphincter InjuryDelivery ComplicationObstetric Complication

Keywords

impedance spectroscopyONIRYmachine learning

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Outcome in Clinically-evaluable (CE) Population with 3-D EUS used as the reference diagnostic method

    The Diagnostic Outcome defined as Diagnostic Success, Diagnostic Failure or Indeterminate, will be programmatically determined for each subject: a. Diagnostic Success: i. occurrence of an anal sphincter injury; or ii. absence of an anal sphincter injury; confirmed consistently by ONIRY and the reference diagnostic method (True Positive, TP, or True Negative, TN, respectively); b. Diagnostic Failure: i. occurrence of anal sphincter injury detected by ONIRY and absence of anal sphincter injury found out using the reference diagnostic method (False Positive, FP) or ii. absence of anal sphincter injury by ONIRY and occurrence of anal sphincter injury found out using the reference diagnostic method (False Negative, FN); c. Diagnostic Indeterminate - all cases in which no ONIRY or reference diagnostic method result is available or interpretable.

    Up to 9 weeks post-partum

Secondary Outcomes (3)

  • Diagnostic Outcome in CE Population with physical rectal examination used as the reference diagnostic method

    Up to 9 weeks post-partum

  • Diagnostic Outcome in CE Population with high-resolution anorectal manometry used as the reference diagnostic method

    Up to 13 weeks post-partum

  • Occurrence of AEs in Safety Population

    Up to 13 weeks post-partum

Other Outcomes (3)

  • Correlation of faecal incontinence symptoms, assessed using Wexner score, with ONIRY, 3-D EUS, physical rectal examination, and high-resolution anorectal manometry results in Safety Population

    Up to 13 weeks post-partum

  • Diagnostic Outcome in CE Population with 3-D EUS used as the reference diagnostic method utilising the classification of anal sphincter injuries according to Starck

    Up to 13 weeks post-partum

  • Diagnostic Outcome in CE Population with 3-D EUS used as the reference diagnostic method utilising the classification of anal sphincter injuries according to Norderval

    Up to 13 weeks post-partum

Study Arms (1)

Impedance spectroscopy

EXPERIMENTAL

ONIRY examination

Diagnostic Test: Laboratory tests: blood and faeces testsDiagnostic Test: Gynaecological and proctological examinationsDiagnostic Test: 3-D Endoanal UltrasoundDevice: ONIRY measurementDiagnostic Test: High-resolution anorectal manometryDiagnostic Test: ECG

Interventions

Laboratory tests: blood and faeces testsDIAGNOSTIC_TEST

To be performed at V2

Impedance spectroscopy
Gynaecological and proctological examinationsDIAGNOSTIC_TEST

To be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy)

Impedance spectroscopy
3-D Endoanal UltrasoundDIAGNOSTIC_TEST

To be performed at V1 (as a reference and for group assignment)

Impedance spectroscopy
ONIRY measurementDEVICE

To be performed at V2 (the electrical impedance of anal sphincter muscles will be measured)

Also known as: Impedance spectroscopy measurement
Impedance spectroscopy
High-resolution anorectal manometryDIAGNOSTIC_TEST

To be performed at V3

Impedance spectroscopy
ECGDIAGNOSTIC_TEST

To be performed at V1 and V2 (for safety reasons)

Impedance spectroscopy

Eligibility Criteria

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

You may qualify if:

  • Women between 18 and 49 years old;
  • Primiparous or multiparous;
  • Since the first moments up to 8 weeks after vaginal delivery (including spontaneous and assisted):
  • of singleton, live foetus,
  • in any presentation,
  • in gestational week 34 or more.
  • For group A:
  • no clinical signs of any degree perineal tear
  • no clinical signs or symptoms of any damage involving anal sphincters;
  • presence of not more than 1 of following OASIS risk factors related to the last delivery: prolonged second phase of delivery, foetal shoulder dystocia, birth weight of the neonate \>4kg, induction of delivery using oxytocin, or head circumference of the neonate ≥34 cm
  • For groups B and C:
  • clinically confirmed 1 or 2-degree perineal tear (including episiotomy and uncontrolled crotch rupture) occurred at the last delivery (for group B);
  • clinically identified 3 or 4-degree perineal tear (damage involving anal sphincters) occurred at the last delivery (regardless of primary repair) (for group C);
  • Signed informed consent form (no proxy or witnessed consent allowed).

You may not qualify if:

  • Any acute, uncontrolled disease (except for haemorrhoidal disease)
  • Chronic diseases not treated or not stable on treatment;
  • Symptoms of faecal incontinence due to a disease other than diagnosed or suspected OASIS;
  • Previous surgery for OASIS (primary or secondary), faecal incontinence or anal prolapse, except for a primary repair of anal sphincter damage performed after the last delivery (allowed);
  • Any surgery in perineal or rectal area, including surgery for OASIS, planned for the study period
  • Presence of inflammatory bowel diseases during exacerbation phase;
  • Any treatment during last 12 months for severe, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness that could increase subject's risk due to participation in the study,
  • Disease other than OASIS so far undiagnosed and reported during the visit V1 or within 7 days prior to it;
  • Present or suspected malignancy or previous oncological treatment in the last 5 years;
  • Implanted cardiac stimulator or cardioverter-defibrillator;
  • Clinically significant cardiac arrhythmias observed in ECG examination or reported in history for the last 12 months;
  • Fever (\>37°C) at enrolment;
  • History of major surgery in perineal or rectal area (other than for OASIS) or severe trauma of perineum or rectum.
  • Use, or need for use, of an anal suppository or other anally administered drug, or cosmetic for the perianal area, within 12 hours prior to impedance spectroscopy examination (visit V2).
  • Positive pregnancy test (only for subjects recruited ≥4 weeks after delivery with no lactation at V1 visit; however, subjects with a positive pregnancy test may be enrolled as long as gynaecologic ultrasound performed at V1 visit shows no signs of a new pregnancy, no sings suggestive of placental tissue remaining in utero, or other abnormality of the uterus).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fakultni nemocnice

Brno, 625 00, Czechia

Location

Ustav pro peci o matku a dite

Prague, 147 10, Czechia

Location

FEMINITY Praktyka Lekarska dr Małgorzata Uchman-Musielak

Warsaw, 05-077, Poland

Location

Gynekologicko-pôrodnícka klinika Nemocnica AGEL Košice-Šaca a.s.

Košice, Košice Region, 040 15, Slovakia

Location

Complejo Asistencial Universitario de Leon

León, 24071, Spain

Location

Related Links

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

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

May 17, 2021

First Posted

May 27, 2021

Study Start

May 20, 2021

Primary Completion

December 8, 2022

Study Completion

December 8, 2022

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)PL(1)CZ(2)SL(1)