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
doi: 10.4121/7e08e77b-f4a9-4054-81a5-e83b7946cb21
,
Aparna Ramanathan
,
Stephen Gwer
,
Robert Bailey
,
Javan Imbamba
,
Stella Odenyo
,
Erin Koksal
,
Jackton Omoto
,
Fredrick Mak'Otieno
,
Jan Carel Diehl
,
Patrick Ongoto
,
Jennipher Auma
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.
- 2024-10-28 first online, published, posted
National Center for Advanced Pelvic Surgery, Department of Obstetrics and Gynecology, Medstar Washington Hospital Center, Georgetown University, Washington, DC, United States.
Nyanza Reproductive Health Society, Kisumu, Kenya.
Department of Epidemiology, University of Illinois at Chicago School of Public Health, Chicago, IL, United States.
Department of Obstetrics and Gynaecology, Maseno University, Kisumu, Kenya
DATA - restricted access
Reason
Study raw data can be accessed upon reasonable request. Data is treated as clinical and requires adherence to ethical procedures. Contact j.c.diehl@tudelft.nl
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Despite anonymisation efforts, the small sample size presents a risk of respondent identification and thus requires careful handling.
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