Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

Obstetric Complication Clinical Trial

Official title:

Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181840
• Other study ID #: 2/1/2019 (May 6)
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: September 2020
• Source: OASIS Diagnostics S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 20, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delivery Complication
• Obstetric Anal Sphincter Injury
• Obstetric Complication
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Poland	Praktyka Lekarska Malgorzata Uchman-Musielak	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
OASIS Diagnostics S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography	Assessment using: OASIS classification of perineal tears.; Starck scale (0-16 scale, no defect - 0, maximum - 16, which means severe damage of both sphincters on a considerable length and circumference).; Norderval scale (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters).	16 weeks
Primary	Anal sphincter tension (function) assessed in physical examination and anorectal manometry		16 weeks
Primary	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	Adverse events	Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.	16 weeks

External Links

•   Sponsor's website