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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Point of Care Ultrasound in Obstetric Triage

NCT05938790

Ultrasound Fetal Monitoring

WITHDRAWN NA

Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study

NCT05802251

Placenta Previa

RECRUITING

Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda

NCT02273037

Stillbirth Neonatal Death

COMPLETED NA

Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio

NCT06265974

Ultrasonography Obstetrics

COMPLETED

Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City

NCT02255903

Pregnancy, Prolonged

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Complication Vaginal Bleeding Eclampsia Preeclampsia Obstructed Labor Antepartum Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

point of care ultrasound

to evaluate the reliability of simple pre-specified ultrasound findings acquired at the bedside with a hand-held apparatus with regards to five clinical scenarios most commonly encountered in the hospital, i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and high risk pregnancies encountered in ANC.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.