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

Pregnancy Related Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pregnancy Related

• NCT number: NCT05765539
• Study type: Interventional
• Source: echOpen Factory
• Contact: Jose F. Fernandes, M.D., Ph.D.
• Phone: +33671135665
• Email: josefernandes@echopenfactory.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Completion date: January 1, 2024