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Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal

NCT05765539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-09-19

No results posted yet for this study

Summary

Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use them. However, the pregnancy follow-up relies in part on the visual investigation by ultrasound scanners that estimate the risks of morbi-mortality for the mother and child during and after pregnancy. The WHO recommendations support at least one ultrasound before 24 weeks of amenorrhea. Thus, at the same time as a usual clinical examination, the possibility of visually assessing certain relevant criteria would help to increase the effectiveness of follow-up visits without complicating the care journey. A simple ultra-portable device would be an opportunity for caregivers to facilitate the detection of complications and thus offer a more adapted follow-up and orientation.

This would allow, in contexts where resources are limited, to improve monitoring and limit the risks of complications due to inappropriate management.

Conditions

  • Pregnancy Related

Interventions

DEVICE

echOpen O1 Handheld Ultrasound device

The performance of the Handheld ultrasound device (echOpen O1 device) will be assessed during these visits for all evaluation criteria. * One examination with the US machine by the midwife focused on 4 targets ; * One examination with a classic US machine by the same midwife (comparator) including the search for the four targets ; * One examination with the US machine by a second operator ; Review of the images obtained by the US machine by the referring radiologist at a separate point of time. The mode of delivery and the vital status of the mother and newborn will also be collected. Operator A will start by using either the echOpen O1 device or the US machine (random order, via sealed envelopes) and will then perform the other type of examination. Another operator (Operator B) will come to perform an examination with the Handheld ultrasound device (blind to the result of the first operator). The switch between operators A and B will also be random.

Sponsors & Collaborators

  • Institut Pasteur de Dakar

    collaborator OTHER

  • Fondation Sanofi Espoir

    collaborator UNKNOWN

  • echOpen Factory

    lead INDUSTRY

Principal Investigators

  • Fatoumata D. Sarr, M.D., MPH · Institut Pasteur de Dakar

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-08-30
Completion
2025-06-19

Countries

  • Senegal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765539 on ClinicalTrials.gov