Overview

This trial is active, not recruiting.

Condition pre-eclampsia
Treatments saline, magnesium sulfate
Sponsor William Marsh Rice University
Collaborator University of Malawi
Start date March 2015
End date December 2016
Trial size 34 participants
Trial identifier NCT02296931, 14-081F

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.
saline
Standard IV Saline Fluids
In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
magnesium sulfate MgSO4
The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)

Primary Outcomes

Measure
Accuracy of flow rate
time frame: 1 day visit

Eligibility Criteria

Female participants at least 18 years old.

Phase 1: Healthy Volunteers Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by William Marsh Rice University.