Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- The intra-operator agreement
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: echOpen O1 Handheld Ultrasound device (Device)
结局指标
主要结局
The intra-operator agreement
时间窗: 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)
次要结局
- The inter-operator agreement(Day 0)