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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Bushra Shahida, PhD
- Numer telefonu: +45 28262484
- E-mail: bushra@oasi.care
Kopia zapasowa kontaktu do badania
- Nazwa: Lone Krebs, MD, PhD
- Numer telefonu: +45 3862 0705
- E-mail: lone.krebs@regionh.dk
Lokalizacje studiów
-
-
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Hvidovre, Dania, 2650
- Amager & Hvidovre Hospital
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Kontakt:
- Lone Krebs, MD, PhD
- Numer telefonu: +45 3862 0705
- E-mail: lone.krebs@regionh.dk
-
Kontakt:
- Bushra Shahida, PhD
- E-mail: bushra@oasi.care
-
Pod-śledczy:
- Catharina Hein Hoffmann, MD
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Pod-śledczy:
- Nanna Bjerg Pagh, Midwife
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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:
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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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Grade 2 Perineal Tears
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Grade ≥2 perineal tears
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Lone Krebs, MD, PhD, Amager & Hvidovre Hospital
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- ASISU-PMCF-HH-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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