Laboratory and Pilot Clinical Assessment of the Accuracy, Usability, and Function of a Low-cost, Low-power Syringe Pump in Administering Magnesium Sulfate to Pre-eclamptic Women in a Low-resource Hospital
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Error in the Total Volume Dispensed and Flow Rate
研究概览
简要总结
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.
- Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP use.
- Eligible and willing participants will provide informed consent. Then, baseline demographic and relevant medical history information will be collected.
- 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.
- 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.
详细描述
The study will recruit patients from two clinical sites (Kamuzu Central Hospital in Lilongwe, Malawi and Queen Elizabeth Central Hospital in Blantyre, Malawi) through their healthcare providers. Malawi represents an ideal location to conduct such a study as there are approximately 17,000 cases of pre-eclampsia annually. The study will include up to 40 women presenting with symptoms of pre-eclampsia.
The study will include pregnant women diagnosed with pre-eclampsia deemed to benefit from treatment with MgSO4 by healthcare providers at our participating clinical sites. Women who are eclamptic or seizing at the time of enrollment or have received MgSO4 therapy within the preceding 24 hours prior to study enrollment will be ineligible.
We will conduct an interventional study of the use of AutoSyP to deliver MgSO4 in two clinical setting in Malawi; Queen Elizabeth Central Hospital and Kamuzu Central Hospital. The study will be open and non-blinded due to ethical considerations that would arise from the denial of the experimental treatment to participants when there is no alternative form of IV MgSO4 delivery available.
All eligible and consenting women will be assigned to have treatment with AutoSyP if an AutoSyP device is available. If an AutoSyP device is not available, the participant will receive treatment for pre-eclampsia according to the standard of care at the hospital.
Pilot Clinical Evaluation Training
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Provide informed consent
- •Agree to comply with study procedures
- •Deemed medically stable by their healthcare provider, including normal range blood pressure.
- •Have been clinically identified to be able to receive standard IV saline fluid
排除标准
- •Women with a history of heart disease of cardiac complications.
- •Women with a history of complications with an IV.
- •Phase 2: Pre-eclamptic Women
- •Inclusion Criteria:
- •18 years of age or older
- •Provide informed consent
- •Agree to comply with study procedures
- •Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
- •Be pregnant or are <24 hours postpartum.
- •Diagnosed with pre-eclampsia and deemed to benefit from treatment with MGSO4 by healthcare providers
- •Exclusion Criteria:
- •Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
- •Be pregnant or are <24 hours postpartum.
研究组 & 干预措施
Healthy Adults
Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.
干预措施: Saline (Other)
Pre-eclamptic pregnant women
In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Error in the Total Volume Dispensed and Flow Rate
时间窗: 1 day visit
This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.
次要结局
未报告次要终点
研究者
Rebecca Richards-Kortum
Stanley C. Moore Professor, Bioengineering
William Marsh Rice University