Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures
The CHLOE-SED STUDY
Start: July 2021
Design: Clinical Trial
Study Sites: Jaramogi Oginga Odinga Teaching and Referral Hospital and Kisii Teaching and Referral Hospital
Sponsor: Grand Challenges Canada
IRB: Jaramogi Oginga Odinga Teaching and Referral Hospital Ethical Review Committee IERC/JOOTRH/485/21
Purpose: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial. Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.
Design: This is a mixed methods study. This study is a single-blinded randomized controlled non- inferiority trial comparing paracervical block administered with the experimental syringe extension device to paracervical block administered with the standard spinal needle. This study involves a single study visit for each enrolled patient and 10 study visits (i.e. 10 study patients) for each enrolled provider. Four focused group discussions (FGD) each enrolling eight Kenyan women, will be conducted to elicit feedback on women’s preferences and experiences regarding pain control during MVA. Two FGDs, each enrolling eight Kenyan MVA providers, will be conducted to elicit feedback on paracervical block performance and the device design.
Population: The study population will include women’s health providers who perform MVA and patients requiring MVA at two sites in Western Kenya: JOOTRH (Jaramogi Oginga Odinga Teaching and Referral Hospital) and KTRH (Kisii Teaching and Referral Hospital) as well as female patients receiving MVA at the two study sites. These women will be determined clinically eligible for MVA treatment by a licensed Kenyan Medical Officer or Clinical Officer who has evaluated them.
Study Size: 21 MVA providers as well as 210 women undergoing MVA will be included in this study. An additional 6 FGDS of 8 members each will also be conducted.
Study Aims: To assess safety of the syringe extension device via data collection on adverse outcomes.
To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.
To gather feedback on device design and improve upon the current model.
To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.
To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.
To assess patients’ experiences and preferences during MVA
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