Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice

NCT07844005 | Not Yet Recruiting DMC

• 1 other identifier: ASISU-PMCF-HH-001
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth. ASISU is a Conformité Européenne (CE)-marked medical device, single-use medical device intended to provide perineal protection during the second stage of vaginal childbirth. Approximately 280 nulliparous participants undergoing eligible vaginal birth at ≥37 weeks of gestation will be prospectively enrolled following ward-level implementation of ASISU. ASISU will be used within its intended purpose and according to the Instructions for Use. Although ASISU is prospectively introduced at ward level as part of the study, use of ASISU in an individual birth remains subject to clinical judgment and is not mandated in every enrolled participant. The study will evaluate implementation of ASISU in routine maternity care and clinical outcomes, including Grade 2 perineal tears. Outcomes following implementation will be compared descriptively with eligible historical pre-implementation routine-care data.

Conditions

Perineal Trauma

Keywords

Perineal tear; Perineal trauma; Vaginal childbirth; Perineal protection; ASISU; Medical device; Implementation science; Medical device implementation; Usability; Workflow integration; Feasibility; Midwifery; Maternity care; Appropriateness; Acceptability

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade 2 Perineal Tears

  Proportion of eligible participants with a documented Grade 2 perineal tear. The numerator is the number of eligible participants with a documented Grade 2 perineal tear and the denominator is the number of eligible participants with known perineal tear grade. Grade 3 and Grade 4 perineal tears are not counted as Grade 2 events and will be reported separately and included in exploratory analyses of Grade ≥2 perineal tears.

  Immediately after vaginal childbirth

Secondary Outcomes (3)

• Incidence of Grade ≥2 perineal tears

  Immediately after vaginal childbirth

• Successful ASISU use

  During vaginal childbirth, assessed immediately after each delivery

• ASISU non-use

  Through completion of the 3-month implementation period

Study Arms (1)

ASISU Ward-Level Implementation

EXPERIMENTAL

Participants enrolled following ward-level implementation of ASISU. ASISU is available for use during the second stage of vaginal childbirth according to its intended purpose and Instructions for Use. Application of ASISU in an individual birth remains subject to clinical judgment and is not mandated for every enrolled participant.

Device: Perineal protection device

Interventions

Perineal protection device DEVICE

ASISU is a CE-marked, single-use perineal protection device intended for use during the second stage of vaginal childbirth. The device is used according to its intended purpose and Instructions for Use. Following ward-level implementation, application in an individual birth is determined by the responsible clinical staff based on clinical circumstances and routine care and is not mandated in every enrolled participant.

ASISU Ward-Level Implementation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous participant
• Gestational age ≥37 completed weeks
• Eligible for vaginal birth
• Meets predefined study eligibility criteria -Written informed consent obtained before study-specific data collection -

You may not qualify if:

• Birth requiring or proceeding to instrumental intervention for the primary efficacy endpoint. If such a conversion occurs after consent, the reason may still be summarized as an implementation interruption where recorded.
• Known perineal abnormality or complication incompatible with ASISU use or requiring surgical intervention during delivery.
• Births involving episiotomy.
• Planned caesarean section or intrapartum conversion to caesarean section for the clinical efficacy analysis.
• Birth in water.
• Genital warts (HPV/condylomata) affecting the perineal area.
• Perineal varices.
• Active genital herpes outbreak.
• Known hypersensitivity or intolerance to ASISU device materials or adhesive.

Sponsors & Collaborators

• oasicare ApS: lead

Study Sites (1)

Amager & Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013 Mar 7;13:59. doi: 10.1186/1471-2393-13-59.

  PMID: 23497085 BACKGROUND

• Opondo C, Harrison S, Sanders J, Quigley MA, Alderdice F. The relationship between perineal trauma and postpartum psychological outcomes: a secondary analysis of a population-based survey. BMC Pregnancy Childbirth. 2023 Sep 6;23(1):639. doi: 10.1186/s12884-023-05950-6.

  PMID: 37674105 BACKGROUND

Study Officials

• Lone Krebs, MD, PhD

  Amager & Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bushra Shahida, PhD

CONTACT

+45 28262484; bushra@oasi.care

Lone Krebs, MD, PhD

CONTACT

+45 3862 0705; lone.krebs@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-group, prospective, non-randomized ward-level implementation study. ASISU is introduced into routine clinical practice following standardized staff training. Enrolled participants constitute the prospective post-implementation study population. Use of ASISU in an individual birth remains subject to clinical judgment and is not mandated in every enrolled participant. Clinical outcomes are compared descriptively with eligible historical pre-implementation routine-care data.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)