Data underlying the publication: Validation of a novel medical device (Chloe SED®) for the administration of analgesia during manual vacuum aspiration: a randomized controlled non-inferiority pilot study

This dataset assesses the efficacy of Chloe SED®, a novel device for administering analgesia during manual vacuum aspiration (MVA), through a multisite, randomized controlled non-inferiority trial aimed at comparing its effectiveness to the standard spinal needle in providing humane care for abortion or miscarriage procedures in low-resource Kenyan healthcare settings. Data captures patient pain tolerance and experiences with Chloe SED® versus the spinal needle, gestational age, prior MVA experiences, reasons for MVA, as well as healthcare providers’ perceptions of pain control and their experience with MVA procedures. The dataset enables a comprehensive comparison of pain control outcomes between Chloe SED® and the standard method, providing insight into the device's potential for improving care quality.

本数据集通过一项多中心随机对照非劣效性试验，评估Chloe SED®——一款用于手动负压吸引术（Manual Vacuum Aspiration, MVA）中实施镇痛的新型设备——的临床有效性。该试验旨在肯尼亚资源匮乏的医疗环境中，对比该设备与标准脊髓穿刺针在流产或稽留流产诊疗操作中提供人道照护的效果。数据集采集的信息涵盖患者的疼痛耐受度、使用Chloe SED®与脊髓穿刺针的操作体验、孕周、既往手动负压吸引术史、接受该操作的原因，以及医护人员对疼痛控制效果的评价与自身开展手动负压吸引术的操作经验。本数据集可实现Chloe SED®与标准镇痛方案的疼痛控制结局全面对比，为阐明该设备改善医疗照护质量的潜在潜力提供科学依据。