Assessment of a Syringe Pump to Pre-eclamptic Women in a Low-resource Hospital

Summary

Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted and relatively inexpensive treatment for these conditions, barriers to delivery via IV injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi. AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure proper procedures are followed. Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women. The study will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia. 1. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use. 2. Eligible and willing participants will provide informed consent. Then, baseline demographic and relevant medical history information will be collected. 3. In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and record device performance and treatment specifications. 4. Subsequent maintenance doses of saline or MgSO4 will be administered and observations monitored and recorded for up to 24 hours as clinically indicated. Others may benefit from this study in the future as AutoSyP is a new delivery system is needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the College of Medicine Library, the Department of Paediatrics, and other partners working in neonatal and child health. Findings will be published in academic journals and conference proceedings in an effort to disseminate results to potential end-users. The research findings of this study will be critical in the evaluation of future interventions.

Timeline

Start

2015-03

Primary completion

2015-10

Completion

2017-10-03

Publications

• Background Duley L, Gulmezoglu AM, Henderson-Smart DJ, Chou D. Magnesium sulphate and other anticonvulsants for women with pre-eclampsia. Cochrane Database Syst Rev. 2010 Nov 10;2010(11):CD000025. doi: 10.1002/14651858.CD000025.pub2.
• Background Connor SB, Quill TJ, Jacobs JR. Accuracy of drug infusion pumps under computer control. IEEE Trans Biomed Eng. 1992 Sep;39(9):980-2. doi: 10.1109/10.256432.
• Skerrett E, Kommwa E, Maynard K, Juarez A, Mataya R, Richards-Kortum R, Oden ZM. Evaluation of a low-cost, low-power syringe pump to deliver magnesium sulfate intravenously to pre-eclamptic women in a Malawian referral hospital. BMC Pregnancy Childbirth. 2017 Jun 19;17(1):191. doi: 10.1186/s12884-017-1382-9.

Drugs

Indications