An observational study in Obstetric Complication, Vaginal Bleeding and Eclampsia Preeclampsia, sponsored by Doctors with Africa - CUAMM. Completed at 1 site in Sierra Leone. Open to female participants. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Doctors with Africa - CUAMM · Observational
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.
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.
90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.
This study's enrollment of 300 is above the median of 122 across 27 observational studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →Doctors with Africa - CUAMM is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
composite reliability of simple obstetric ultrasound findings collected by hand held ultrasound devices in a busy urban low resource setting.
the mean aggregated diagnostic accuracy between the ultrasound findings collected via hand held devices as compared to the conventional apparatus.
Time frame: From admission to 48 hours later
reliability for each pre-defined ultrasound finding
Detailed diagnostic accuracy for each of the nine ultrasound findings.
Time frame: From admission to 48 hours later
variance of the reliability between naïve and intermediate operators.
Inter-observer agreement on ultrasound findings between naïve and intermediate operators.
Time frame: From admission to 48 hours later
quality of images acquired with the hand held apparatus.
Mean 'quality of image score' (0-4) for each of the nine ultrasound findings.
Time frame: From admission to 48 hours later
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2019 to primary completion in Apr 2019, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Doctors with Africa - CUAMM