Validation of a novel medical device (Chloe SED®) for the administration of analgesia during manual vacuum aspiration
a randomized controlled non-inferiority pilot study
A Ramanathan (Nyanza Reproductive Health Society, Georgetown University)
K.T. Samenjo (TU Delft - Design for Sustainability, Nyanza Reproductive Health Society)
Robert C. Bailey (Nyanza Reproductive Health Society, University of Illinois at Chicago)
Javan Imbamba (Nyanza Reproductive Health Society)
Stella Odenyo (Nyanza Reproductive Health Society, Maseno University)
Erin Koksal (Independent researcher)
J.C. Diehl (TU Delft - Design for Sustainability)
Jackton Omoto (Maseno University)
Stephen Gwer (Nyanza Reproductive Health Society, Maseno University)
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Abstract
Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools.
Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs—three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no:RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction.
Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1–4.6] compared with the spinal needle at 4.1 (90% CI: 3.5–4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device to administer PCB for MVA. No adverse events were noted.
Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA.
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