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

September 15, 2025 updated by: echOpen Factory

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The echOpen O1 Ultrasound Probe is a medical device designed to guide the diagnosis during clinical examination by providing a non-invasive, non-irradiant inside body image.

The investigator's hypothesis is that the use of this ultrasound stethoscopy probe during pregnancy, by a trained midwife, would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, the investigators propose a pilot study to evaluate, under field conditions, the performance of the echOpen O1 probe as part of the 3rd-trimester pregnancy monitoring, compared to a standard ultrasound examination, routinely performed with an ultrasound machine.

The main objective of this prospective pilot study is to evaluate the performance and operationality of the echOpen O1 probe from the 37th week of amenorrhea.

The secondary objectives are :

  • To evaluate the feasibility and usability of the echOpen O1 probe in the context of pregnancy monitoring by midwives and in zone field conditions:

    • One urban health center (Centralized)
    • One rural health center (Decentralized)
  • Assess women's quality of life during pregnancy and obtain satisfaction with echOpen O1 probe.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Senegal
    • Fatick
      • Karang, Fatick, Senegal
        • Poste de Santé de Karang
      • Sokone, Fatick, Senegal
        • Centre de Santé de Sokone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnancy ≥ 37 weeks of amenorrhea
  • Women aged ≥ 18 years old
  • Delivery scheduled to take place in the recruitment center
  • Have given her written informed consent to participate

Exclusion Criteria:

  • Known fetal morphological abnormality
  • Emergency context during the participant's management
  • Obstetrical work in progress
  • Women anticipating displacement or no delivery at the clinical site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregnant women benefitting ultrasound examination
This is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks.
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.

Other Names:
  • Multicentric prospective comparative study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intra-operator agreement
Time Frame: Day 0

The intra-operator agreement will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are:

The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an intra-operator concordance, the images for the 4 ultrasound targets (collected by the same operator) must be identical for both devices (echOpen probe and Ultrasound device routinely used in pregnant women)
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The inter-operator agreement
Time Frame: Day 0

The inter-operator concordance will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are:

The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an inter-operator concordance, the images on the 4 ultrasound targets (collected by two different operators) must be identical for the same device (echOpen probe).

All ultrasound images will go to the radiologist for review and validation. This review will be done blindly of the result provided by the operators.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

echOpen Factory

Collaborators

Institut Pasteur de Dakar
Fondation Sanofi Espoir

Investigators

  • Principal Investigator: Fatoumata D. Sarr, M.D., MPH, Institut Pasteur de Dakar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

June 19, 2025

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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