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

NCT03856307 | Completed

• 1 other identifier: 01-2019
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstetric Complication; Vaginal Bleeding; Eclampsia Preeclampsia; Obstructed Labor; Antepartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• reliability for each pre-defined ultrasound finding

  From admission to 48 hours later

• variance of the reliability between naïve and intermediate operators.

  From admission to 48 hours later

• quality of images acquired with the hand held apparatus.

  From admission to 48 hours later

Interventions

point of care ultrasound DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Admitted to the emergency department, outpatient department, in-patient department or antenatal care (ANC) of the PCMH during the study period.

You may not qualify if:

• Ultrasound examination not feasible, e.g., due to electricity breakdown, or physical absence or unavailability of the trained sonographers.

Sponsors & Collaborators

• Doctors with Africa - CUAMM: lead

Study Sites (1)

Princess Christian Maternal Hospital

Freetown, Sierra Leone

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Dystocia

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: March 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

SI (1)