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临床试验/NCT03856307
NCT03856307已完成不适用

Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis in an Urban Low Resource Setting

Doctors with Africa - CUAMM1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
composite reliability of simple obstetric ultrasound findings collected by hand held ultrasound devices in a busy urban low resource setting.

研究概览

简要总结

the study aims to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.

详细描述

Rationale: The majority of obstetric emergencies are identified through clinical examination, which cannot be substituted by ultrasound. However, just as a laboratory exam, ultrasonograpy can provide swift point of care information on fetus presentation, viability, placenta position, quantity of amniotic fluid and presence of abdominal fluid to inform the clinical reasoning and therapeutic escalation. Ultrasound literature in low-resource settings has favoured antenatal care (ANC) rather than the emergency setting. Also, hand-held ultrasound machines may not be as performant as traditional machines used by expert operators but to date is still to be tested in a low resource setting.

Objective: to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.

Hypothesis: There is substantial agreement between simple ultrasound findings identified using hand held ultrasound devices and the reference standard.

Study design: a prospective observational diagnostic accuracy study. Study population: parturients admitted to the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.

Sample size: no formal sample size calculation is performed. Based on current rates of admissions to the PCMH we expect to perform obstetrical ultrasound scan in at least 300 patients during a 2-months study period.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Admitted to the emergency department, outpatient department, in-patient department or antenatal care (ANC) of the PCMH during the study period.
  • Fulfills one or more of the five inclusion categories: i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and other high risk pregnancies encountered in ANC.

排除标准

  • Ultrasound examination not feasible, e.g., due to electricity breakdown, or physical absence or unavailability of the trained sonographers.

结局指标

主要结局

composite reliability of simple obstetric ultrasound findings collected by hand held ultrasound devices in a busy urban low resource setting.

时间窗: From admission to 48 hours later

the mean aggregated diagnostic accuracy between the ultrasound findings collected via hand held devices as compared to the conventional apparatus.

次要结局

  • reliability for each pre-defined ultrasound finding(From admission to 48 hours later)
  • variance of the reliability between naïve and intermediate operators.(From admission to 48 hours later)
  • quality of images acquired with the hand held apparatus.(From admission to 48 hours later)

研究者

发起方
Doctors with Africa - CUAMM
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuichi Kodaira

Medical Doctor

Doctors with Africa - CUAMM

研究点 (1)

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