Reliability of Simple Sonographic Findings Acquired With Hand-held

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

Methods: 4 trained physicians (3 naive and 1 intermediate ultrasound users) will perform the ultrasound investigations using the hand held device and complete a structured predefined report form of obstetric ultrasound findings at patient admission or according to clinical indications after admission. These will be compared with the reference standard, i.e. an ultrasound examination performed by a specialist gynecologist/obstetrician using a conventional apparatus in the hospital ultrasound room.

Main study parameters/primary endpoints: The mean diagnostic accuracy among nine ultrasound obstetric findings collected with hand held devices versus the reference standard. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03856307
Study type	Observational [Patient Registry]
Source	Doctors with Africa - CUAMM
Contact
Status	Completed
Phase
Start date	March 1, 2019
Completion date	June 1, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms