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临床试验/NCT05046704
NCT05046704已完成不适用

Accuracy of Peripartum Ultrasound in the Prediction and Diagnosis of Obstetric Anal Sphincter Injuries

Cairo University1 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2021年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,250
试验地点
1
主要终点
Obstetric Anal Sphincter Injuries(OASIs) as diagnosed on clinical examination

研究概览

简要总结

To determine the value of peripartum scan measurement(s) in the prediction and diagnosis of Obstetric Anal Sphincter Injuries (OASIs)

详细描述

1.1.Obstetric Anal Sphincter Injuries (OASIs) Obstetric anal sphincter injuries (OASIs) are serious complications of vaginal birth with a reported incidence throughout Europe and globally, from 1-10% with recent UK data demonstrating a steadily rising incidence of this type of trauma over the past 12 years .

OASIs is one of the most significant risk factors for anal incontinence in young women as well as other complications of long-term dyspareunia and perineal pain.Despite optimal primary repair, approximately 39% of women who sustain an OASIs will suffer from anal incontinence. Several studies have reported a much higher risk of anal incontinence with subsequent deliveries and the potential for symptoms to progress with time.

1.2. Prediction of OASIs With the wealth of population based databases that are now available prediction models are being developed to assist in clinical decision making. Several large population based cohort studies have identified various independent risk factors for sustaining primary or recurrent OASIS. These include nulliparity, increased birth weight, operative vaginal delivery, persistent occipito-posterior position, prolonged pushing phase, induction of labour, use of epidural analgesia and shoulder dystocia, although findings across studies are contradictory.However there is paucity of information relating to the impact of risk factors that can only be known prior to the actual birth both on the likelihood of OASIs occurring de-novo and the usefulness of such information for counselling women at potential risk of sustaining a primary OASIs.

Although members of the investigators group have previously demonstrated that some of these prediction models have been suggested to have good discriminatory value, they do not necessarily confer a good clinical value. Although the model was useful in ruling out risk of OASIs in women with no risk factors, it was not as good in ruling-in an OASIS - that means that a women presenting with all of the known clinical risk factors cannot be differentiated at any higher risk than a women with a smaller subset of these risk factors. Hence limiting its clinical usability.

1.3. Ultrasound and OASIs management Transperineal and endoanal ultrasound scanning is currently used for the diagnosis and management of OASIs. Indeed, they form part of the recommended practice for determining the best mode of birth in pregnancies following OASIs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous .
  • Term, Vertex, Singleton living pregnancy.
  • Maternal age 18 years or over.

排除标准

  • Exclusion criteria are those who do not fit in the inclusion criteria.

结局指标

主要结局

Obstetric Anal Sphincter Injuries(OASIs) as diagnosed on clinical examination

时间窗: baseline

Detection the accuracy of peripartum transperineal US in prediction and diagnosis of obstetric anal sphincter injuries by measuring the ano vaginal distance in mm using vaginal probe of US and measuring the sub-pubic angle ueing 3D/4D probe of US intrapartum and using rolling technique postnatally for detection of occurrence of OASIs.

次要结局

  • 2-Duration of second stage(baseline)
  • 1- Other degrees of perineal trauma(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Niven Abu Al-Foutouh Adly Shaban

Assistant Lecturer

Cairo University

研究点 (1)

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