Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

• ClinicalTrials.gov Identifier: NCT04181840
• Recruitment Status: Completed
• First Posted: December 2, 2019
• Last Update Posted: September 16, 2020
• Sponsor: OASIS Diagnostics S.A.
• Information provided by (Responsible Party): OASIS Diagnostics S.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstetric Anal Sphincter Injury; Delivery Complication; Obstetric Complication	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries
• Actual Study Start Date: October 15, 2019
• Actual Primary Completion Date: June 26, 2020
• Actual Study Completion Date: July 20, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. Anal sphincter tension (function) assessed in physical examination and anorectal manometry [ Time Frame: 16 weeks ]
3. 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.

Secondary Outcome Measures :

1. Adverse events [ Time Frame: 16 weeks ]
   Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Poland

Praktyka Lekarska Małgorzata Uchman-Musielak

Warsaw, Mazowieckie, Poland, 05-077

Sponsors and Collaborators

OASIS Diagnostics S.A.

Investigators

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

More Information

Additional Information:

Sponsor's website 

• Responsible Party: OASIS Diagnostics S.A.
• ClinicalTrials.gov Identifier: NCT04181840
• Other Study ID Numbers: 2/1/2019 (May 6)
• First Posted: December 2, 2019
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by OASIS Diagnostics S.A.:

Obstetric Anal Sphincter Injury; Impedance Spectroscopy

Additional relevant MeSH terms:

Wounds and Injuries