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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Complication; Vaginal Bleeding; Eclampsia Preeclampsia; Antepartum Hemorrhage; Obstructed Labor
• Intervention / Treatment: Diagnostic test: point of care ultrasound

Detailed 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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Sierra Leone
  • Freetown, Sierra Leone
    • Princess Christian Maternal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• Vaginal bleeding in early pregnancy:Vaginal bleeding or cramping, with amenorrhea or positive pregnancy test <22 weeks of gestation
• Pre-eclampsia:Blood pressure ≥140/90 (at least 2 recordings, 4 hours apart) PLUS any of: proteinuria (at least 2+ on dipstick, headache, generalized oedema, visual disturbance).
• APH third trimester: Vaginal bleeding after 22 weeks of pregnancy or in labour before giving birth. May have final diagnosis of abruptio placentae, placenta previa and ruptured uterus.
• Prolonged/Obstructed labour: Prolonged latent or active phase, cephalopelvic disproportion, obstructed labor, inadequate uterine activity, prolonged expulsive phase.
• High risk pregnancy in ANC defined by hospital protocol

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
reliability for each pre-defined ultrasound finding	Detailed diagnostic accuracy for each of the nine ultrasound findings.	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.	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.	From admission to 48 hours later

Collaborators and Investigators

• Sponsor: Doctors with Africa - CUAMM

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Pregnancy Complications; Obstetric Labor Complications; Hypertension, Pregnancy-Induced; Hemorrhage; Eclampsia; Pre-Eclampsia; Dystocia; Uterine Hemorrhage
• Other Study ID Numbers: 01-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No