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

2026年9月24日 更新者：oasicare ApS

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

280

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Bushra Shahida, PhD
  • 电话号码：+45 28262484
  • 邮箱：bushra@oasi.care

研究联系人备份

学习地点

  • 丹麦
      • Hvidovre、丹麦、2650
        • Amager & Hvidovre Hospital
        • 接触：
        • 接触：
        • 副研究员：
          • Catharina Hein Hoffmann, MD
        • 副研究员：
          • Nanna Bjerg Pagh, Midwife

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：Perineal protection device

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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Grade 2 Perineal Tears
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Incidence of Grade ≥2 perineal tears
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

oasicare ApS

调查人员

  • 首席研究员：Lone Krebs, MD, PhD、Amager & Hvidovre Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月19日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年9月18日

首先提交符合 QC 标准的

2026年9月24日

首次发布 (实际的)

2026年9月28日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ASISU-PMCF-HH-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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