Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice (ASISU-PMCF)
Ward-Level Implementation and Observational Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
ASISU is a CE-marked, single-use perineal protection device intended for use during the second stage of vaginal childbirth.
This study prospectively introduces ASISU at ward level within routine maternity care and evaluates its implementation and clinical performance. Midwives and relevant clinical staff will receive standardized training in use of ASISU before implementation.
Approximately 280 evaluable nulliparous participants undergoing eligible vaginal birth at ≥37 weeks of gestation will be prospectively enrolled. ASISU will be used within its intended purpose and according to the Instructions for Use.
Enrollment does not mandate application of ASISU in every individual birth. The responsible clinical staff retain discretion regarding whether ASISU is used according to the clinical circumstances, maternal preference and routine care.
Prospective clinical data will include ASISU use, non-use and discontinuation, reasons for non-use or discontinuation, episiotomy, perineal tear degree and type, maternal birthing position, maternal characteristics and infant birth weight.
The primary clinical outcome is the incidence of Grade 2 perineal tears. Outcomes following implementation will be compared descriptively with an eligible historical pre-implementation reference cohort derived from routine-care data, provided compatible outcome definitions and denominators are available.
Implementation outcomes include staff training and competency, integration into clinical workflow, successful device use, discontinuation and reasons for non-use.
The study does not involve randomization, blinding, use of ASISU outside its intended purpose, or additional invasive or burdensome clinical procedures.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Bushra Shahida, PhD
- Telefonnummer: +45 28262484
- E-mail: bushra@oasi.care
Undersøgelse Kontakt Backup
- Navn: Lone Krebs, MD, PhD
- Telefonnummer: +45 3862 0705
- E-mail: lone.krebs@regionh.dk
Studiesteder
-
-
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Hvidovre, Danmark, 2650
- Amager & Hvidovre Hospital
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Kontakt:
- Lone Krebs, MD, PhD
- Telefonnummer: +45 3862 0705
- E-mail: lone.krebs@regionh.dk
-
Kontakt:
- Bushra Shahida, PhD
- E-mail: bushra@oasi.care
-
Underforsker:
- Catharina Hein Hoffmann, MD
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Underforsker:
- Nanna Bjerg Pagh, Midwife
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ASISU Ward-Level Implementation
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. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Grade 2 Perineal Tears
Tidsramme: Immediately after vaginal childbirth
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Grade ≥2 perineal tears
Tidsramme: Immediately after vaginal childbirth
|
Proportion of eligible participants experiencing Grade 2, Grade 3 or Grade 4 perineal tears. |
Immediately after vaginal childbirth
|
|
Successful ASISU use
Tidsramme: During vaginal childbirth, assessed immediately after each delivery
|
Number and proportion of births in which ASISU use was attempted and successfully completed without device discontinuation. |
During vaginal childbirth, assessed immediately after each delivery
|
|
ASISU non-use
Tidsramme: Through completion of the 3-month implementation period
|
Number and proportion of enrolled eligible births in which ASISU was not used, including documented reasons for non-use. |
Through completion of the 3-month implementation period
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lone Krebs, MD, PhD, Amager & Hvidovre Hospital
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ASISU-PMCF-HH-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
There is currently no plan to share individual participant data. Any future data sharing would be subject to applicable data protection requirements, participant confidentiality, and relevant institutional and ethical approvals.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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