Ward-level use of ASISU to protect the perineum during vaginal birth
Official title: Ward-Level Implementation and Observational Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
Run by oasicare ApS · NCT07844005 · Data updated 2026-11-12
This study tests whether using the ASISU perineal protection device during routine vaginal births in first-time mothers can reduce Grade 2 perineal tears.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 280 (estimated) |
| Sponsor | oasicare ApS Industry-sponsored |
| Locations | 1 site (Hvidovre) |
| Status | Recruiting |
| Started | November 4, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | May 28, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07844005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Nulliparous women at ≥37 weeks gestation planning vaginal delivery and eligible for ASISU use, with informed consent.
✕Probably not a fit
Patients needing instrumental delivery or with contraindications to ASISU use may not benefit and are excluded from primary endpoints.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, non-randomized post-market follow-up of ASISU used in routine vaginal childbirth. Approximately 280 nulliparous women at ≥37 weeks gestation will be enrolled after ward-level implementation, with usage at clinical discretion and according to the device instructions. Training will be provided to midwives and staff before implementation, and data will capture ASISU use, reasons for non-use or discontinuation, episiotomy, perineal tear details, birth position, maternal characteristics, and infant birth weight. The primary outcome is the incidence of Grade 2 perineal tears, compared descriptively with a historical pre-implementation cohort using compatible definitions. Additional implementation outcomes include staff training competency and integration into workflow.
Why it matters
Potential benefit: If successful, ASISU could help reduce perineal trauma during vaginal birth and improve maternal outcomes.
How similar studies have gone: Past studies of perineal protection devices have shown mixed results; this study adds real-world, ward-level implementation data in a post-market setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Amager & Hvidovre Hospital
Hvidovre, Denmark Recruiting
Study contacts
- Principal investigator: Lone Krebs, MD, PhD — Amager & Hvidovre Hospital
- Study coordinator: Bushra Shahida, PhD
- Email: bushra@oasi.care
- Phone: +45 28262484
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Hands-on versus hands-off perineal protection during vaginal birth
This study will test whether hands-on or hands-off perineal support during vaginal birth better prevents perineal tears and affects newborn well-being for women delivering head-first at term.
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Care pathways for women with obstetric anal sphincter injury-related incontinence
This study looks at how women with incontinence from childbirth-related injuries are currently cared for to see if better support can be provided.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.