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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

Female

Healthy volunteers

Accepted

Participants

280 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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 -

Exclusion Criteria:

• 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.
• For the prospective observational cohort: inability or unwillingness to provide valid informed consent excludes the individual from enrolment and from inclusion of her individual-level data in the study dataset. It does not, in itself, constitute a clinical contraindication to routine use of ASISU.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

oasicare ApS

Study start

Nov 4, 2026 Actual

Primary completion

Feb 28, 2027 Estimated

Study completion

May 28, 2027 Estimated

First posted

Sep 28, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts