Obstetric Complication Clinical Trial
Official title:
Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis in an Urban Low Resource Setting
NCT number | NCT03856307 |
Other study ID # | 01-2019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | June 1, 2019 |
Verified date | July 2019 |
Source | Doctors with Africa - CUAMM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. Exclusion Criteria: - Ultrasound examination not feasible, e.g., due to electricity breakdown, or physical absence or unavailability of the trained sonographers. |
Country | Name | City | State |
---|---|---|---|
Sierra Leone | Princess Christian Maternal Hospital | Freetown |
Lead Sponsor | Collaborator |
---|---|
Doctors with Africa - CUAMM |
Sierra Leone,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From admission to 48 hours later | |
Secondary | reliability for each pre-defined ultrasound finding | Detailed diagnostic accuracy for each of the nine ultrasound findings. | From admission to 48 hours later | |
Secondary | variance of the reliability between naïve and intermediate operators. | Inter-observer agreement on ultrasound findings between naïve and intermediate operators. | From admission to 48 hours later | |
Secondary | quality of images acquired with the hand held apparatus. | Mean 'quality of image score' (0-4) for each of the nine ultrasound findings. | From admission to 48 hours later |
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