Validation of a Novel Reusable Vacuum Extractor

Abstract

Abstract—Background: Vacuum extraction is a way to prevent unnecessary maternal deaths, by using a vacuum extractor to help deliver the baby in the second stage of labour. Vacuum extraction is still little-used in low- and middle-income countries (LMIC) compared to high-income countries, due to the lack of sufficient devices on the market that fit the local context. For this purpose, a novel reusable and affordable vacuum extractor was designed. This study compares this device, the VelaTM, with a commonly used vacuum extractor, the Kiwi Omnicup®, in terms of performance and user experience in a non-inferiority mannequin study. Methods: Obstetricians and residents from LUMC and CWZ hospitals performed a vacuum extraction on a birthing mannequin using both devices. During simulated “traction windows” of 25 seconds, the participant was allowed to pull. The primary endpoint was the traction window in which successful vacuum extraction occurred. Secondary endpoints were the total number of pop-offs of the cup, the exact success time within the successful traction window, the pumping time before the successful traction window, the satisfaction rate and the comparison between the two devices on placement, pumping and pulling. Finally, the participants were asked for their opinions about the Vela in an open-ended question. Results: A total of 47 participants were included in this study, of which three never achieved success with the Vela. For the primary endpoint, the Vela was non-inferior to the Kiwi in both LUMC and CWZ. Furthermore, no significant differences were found between the Vela and the Kiwi regarding any of the secondary endpoints, with the exception of the satisfaction rate in the LUMC. This was significantly lower for the Vela. Themes raised by participants concerned the stiffness of the Vela tube, the comfort of the Vela during usage and the need for familiarization with a new device. Conclusions: The results of this study indicate that the Vela is non-inferior to the Kiwi Omnicup when used by clinicians who had success with both devices, however there is room for improvement regarding satisfaction of the Vela. More familiarization is needed and the tube of the Vela should be reduced in stiffness. With this initial validation, the Vela can be seen as a promising alternative for LMIC, and can be further optimized into a high-quality fully reusable vacuum extractor.