Pregnancy Related
Conditions
Keywords
Medical Device, Handheld Ultrasound, Echostethoscopy
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.
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.
Interventions
DEVICEechOpen 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
Institut Pasteur de Dakar
Fondation Sanofi Espoir
echOpen Factory
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Midwife 'A' will begin by using either the echOpen probe or the classic US machine (in a random order, via sealed envelopes), and will then carry out the other type of examination. The results book will be filled in and validated after each examination, and it will not be possible to modify the results after the 2nd examination has been carried out. Another midwife (midwife 'B') will examine with the echOpen probe (blind to the first midwife's result). The alternation between midwife 'A' and midwife 'B' will also be random.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Senegal
Outcome results
None listed