Assessment of a Syringe Pump to Pre-eclamptic Women in a Low-resource Hospital
Status:
Completed
Trial end date:
2017-10-03
Target enrollment:
Participant gender:
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.