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Status:

COMPLETED

Detection of Obstetric Anal Sphincter Injuries With ONIRY Device

Lead Sponsor:

OASIS Diagnostics S.A.

Collaborating Sponsors:

National Center for Research and Development, Poland

Conditions:

Obstetric Anal Sphincter Injury

Delivery Complication

Eligibility:

FEMALE

18-49 years

Phase:

NA

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 deliv...

Detailed Description

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 deliv...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

  • 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).

Key Trial Info

Start Date :

May 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 8 2022

Estimated Enrollment :

152 Patients enrolled

Trial Details

Trial ID

NCT04903977

Start Date

May 20 2021

End Date

December 8 2022

Last Update

January 22 2024

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Fakultni nemocnice

Brno, Czechia, 625 00

2

Ustav pro peci o matku a dite

Prague, Czechia, 147 10

3

FEMINITY Praktyka Lekarska dr Małgorzata Uchman-Musielak

Warsaw, Poland, 05-077

4

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

Košice, Košice Region, Slovakia, 040 15