Jaufuraully Shireen, Salvadores Fernandez Carmen, Bagchi Biswajoy, Gupta Priya, Desjardins Adrien, Siassakos Dimitrios, David Anna L, Tiwari Manish K
Wellcome/EPSRC Centre for Interventional and Surgical Sciences, University College London, London, United Kingdom.
Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, United Kingdom.
Front Glob Womens Health. 2023 Jan 30;3:1039477. doi: 10.3389/fgwh.2022.1039477. eCollection 2022.
98% of stillbirths occur in low- and middle- income countries. Obstructed labor is a common cause for both neonatal and maternal mortality, with a lack of skilled birth attendants one of the main reasons for the reduction in operative vaginal birth, especially in low- and middle- income countries. We introduce a low cost, sensorized, wearable device for digital vaginal examination to facilitate accurate assessment of fetal position and force applied to the fetal head, to aid training in safe operative vaginal birth.
The device consists of flexible pressure/force sensors mounted onto the fingertips of a surgical glove. Phantoms of the neonatal head were developed to replicate sutures. An Obstetrician tested the device on the phantoms by performing a mock vaginal examination at full dilatation. Data was recorded and signals interpreted. Software was developed so that the glove can be used with a simple smartphone app. A patient and public involvement panel was consulted on the glove design and functionality.
The sensors achieved a 20 Newton force range and a 0.1 Newton sensitivity, leading to 100% accuracy in detecting fetal sutures, including when different degrees of molding or caput were present. They also detected sutures and force applied with a second sterile surgical glove on top. The software developed allowed a force threshold to be set, alerting the clinician when excessive force is applied. Patient and public involvement panels welcomed the device with great enthusiasm. Feedback indicated that women would accept, and prefer, clinicians to use the device if it could improve safety and reduce the number of vaginal examinations required.
Under phantom conditions to simulate the fetal head in labor, the novel sensorized glove can accurately determine fetal sutures and provide real-time force readings, to support safer clinical training and practice in operative birth. The glove is low cost (approximately 1 USD). Software is being developed so fetal position and force readings can be displayed on a mobile phone. Although substantial steps in clinical translation are required, the glove has the potential to support efforts to reduce the number of stillbirths and maternal deaths secondary to obstructed labor in low- and -middle income countries.
98%的死产发生在低收入和中等收入国家。梗阻性分娩是新生儿和孕产妇死亡的常见原因，缺乏熟练的助产人员是导致阴道助产分娩减少的主要原因之一，尤其是在低收入和中等收入国家。我们推出了一种低成本、带有传感器的可穿戴数字阴道检查设备，以促进对胎儿位置和施加于胎儿头部的力量进行准确评估，辅助安全阴道助产分娩的培训。
该设备由安装在手术手套指尖的柔性压力/力传感器组成。制作了新生儿头部模型以复制缝线。一名产科医生通过在完全扩张时进行模拟阴道检查，在模型上测试了该设备。记录数据并解读信号。开发了软件，以便该手套可与简单的智能手机应用程序配合使用。就手套的设计和功能咨询了患者及公众参与小组。
传感器的力范围为20牛顿，灵敏度为0.1牛顿，在检测胎儿缝线时准确率达100%，包括存在不同程度的头颅塑形或产瘤时。它们还能检测到上面套着第二只无菌手术手套时施加的缝线和力。所开发的软件允许设置力阈值，当施加过大力量时向临床医生发出警报。患者及公众参与小组对该设备表现出极大热情。反馈表明，如果该设备能提高安全性并减少所需的阴道检查次数，女性会接受并更希望临床医生使用它。
在模拟分娩时胎儿头部的模型条件下，这种新型带传感器的手套能够准确确定胎儿缝线并提供实时力读数，以支持更安全的阴道助产临床培训和实践。该手套成本低（约1美元）。正在开发软件以便能在手机上显示胎儿位置和力读数。尽管在临床转化方面还需要迈出重大步伐，但该手套有潜力助力减少低收入和中等收入国家因梗阻性分娩导致的死产和孕产妇死亡数量。
