TY - DATA T1 - 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 PY - 2024/10/28 AU - Karlheinz Samenjo AU - Aparna Ramanathan AU - Stephen Gwer AU - Robert Bailey AU - Javan Imbamba AU - Stella Odenyo AU - Erin Koksal AU - Jackton Omoto AU - Fredrick Mak'Otieno AU - Jan Carel Diehl UR - DO - 10.4121/7e08e77b-f4a9-4054-81a5-e83b7946cb21.v1 KW - Clinical trial KW - medical device design KW - paracervical block KW - manual vacuum aspiration KW - abortion care N2 -

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.

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