Perineal TraumaASISU-PMCFNCT07844005
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
A study testing Perineal protection device in people with Perineal Trauma, run by oasicare ApS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Trauma
- What is being tested?
- Perineal protection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Amager & Hvidovre Hospital
Hvidovre, 2650
Lone Krebs, MD, PhD, +45 3862 0705, lone.krebs@regionh.dk
Bushra Shahida, PhD, bushra@oasi.care
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Perineal Trauma
- Being tested
- Perineal protection device
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal protection deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Perineal protection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after vaginal childbirth
Secondary outcomes (3)
Incidence of Grade ≥2 perineal tears
Proportion of eligible participants experiencing Grade 2, Grade 3 or Grade 4 perineal tears.
Measured: Immediately after vaginal childbirth
Successful ASISU use
Number and proportion of births in which ASISU use was attempted and successfully completed without device discontinuation.
Measured: During vaginal childbirth, assessed immediately after each delivery
ASISU non-use
Number and proportion of enrolled eligible births in which ASISU was not used, including documented reasons for non-use.
Measured: Through completion of the 3-month implementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perineal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- oasicare ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lone Krebs, MD, PhD, Principal investigator, Amager & Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844005
- Sponsor's protocol ID
- ASISU-PMCF-HH-001
- Acronym
- ASISU-PMCF
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23497085Opondo 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.
PubMed 37674105
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ward-Level Implementation and Observational Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT07844005
- Acronym / sponsor ID
- ASISU-PMCF / ASISU-PMCF-HH-001
- Conditions
- Perineal Trauma
- Keywords
- Perineal tear, Perineal trauma, Vaginal childbirth, Perineal protection, ASISU, Medical device, Implementation science, Medical device implementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- oasicare ApSIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASISU Ward-Level Implementation | Experimental | Device: Perineal protection deviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal protection deviceASISU 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. | Device | ASISU Ward-Level Implementation |
Primary outcome
Incidence of Grade 2 Perineal Tears
Time frame: 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.
3 secondary outcomes
Incidence of Grade ≥2 perineal tears
Time frame: Immediately after vaginal childbirth
Successful ASISU use
Time frame: During vaginal childbirth, assessed immediately after each delivery
ASISU non-use
Time frame: Through completion of the 3-month implementation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 23497085Smith 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.
- Background: PubMed 37674105Opondo 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Perineal Trauma
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
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Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lone Krebs, MD, PhD principal investigator
Amager & Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal protection device in people with Perineal Trauma, run by oasicare ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bushra Shahida, PhD (+45 28262484, bushra@oasi.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 2 Perineal Tears (time frame: Immediately after vaginal childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07844005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.