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

Sponsor
echOpen Factory (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05765539
Collaborator
Institut Pasteur de Dakar (Other), Fondation Sanofi Espoir (Other)
220
Enrollment
1
Arm
9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: echOpen O1 Handheld Ultrasound device
 N/A

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.

Our hypothesis is that, with the support of a midwife trained in the use of this ultrasound stethoscopy probe, its use during pregnancy would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, we 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 Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe used in the department.A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe used in the department.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The intra-operator agreement [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)

    Secondary Outcome Measures

    1. The inter-operator agreement [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • echOpen Factory
    • Institut Pasteur de Dakar
    • Fondation Sanofi Espoir

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    echOpen Factory
    ClinicalTrials.gov Identifier:
    NCT05765539
    Other Study ID Numbers:
    • 2023-P01
    First Posted:
    Mar 13, 2023
    Last Update Posted:
    Mar 13, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by echOpen Factory
    Medical Device
    Handheld Ultrasound
    Echostethoscopy

    Study Results

    No Results Posted as of Mar 13, 2023