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

echOpen

Status: Completed

Conditions: Pregnancy Related

Treatments: Device: echOpen O1 Handheld Ultrasound device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05765539

2023-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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224 participants in 1 patient group

Pregnant women benefitting ultrasound examination

Experimental group

Description:

This is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks.

Treatment:

Device: echOpen O1 Handheld Ultrasound device