Status:
COMPLETED
Assessment of a Syringe Pump to Pre-eclamptic Women in a Low-resource Hospital
Lead Sponsor:
William Marsh Rice University
Collaborating Sponsors:
University of Malawi
Conditions:
Pre-eclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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-resou...
Detailed Description
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. Malaw...
Eligibility Criteria
Inclusion
- Phase 1: Healthy Volunteers
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02296931
Start Date
March 1 2015
End Date
October 3 2017
Last Update
November 6 2017
Active Locations (1)
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1
Queen Elizabeth Central Hospital
Blantyre, Malawi