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Treatment Approaches for Preeclampsia in Low-Resource Settings

Treatment Approaches for Preeclampsia in Low-Resource Settings

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00666133
Enrollment
304
Registered
2008-04-24
Start date
2008-04-30
Completion date
2009-10-31
Last updated
2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, Eclampsia, Magnesium Sulfate

Brief summary

Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia. Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits. The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.

Interventions

DEVICESpringFusor Pump

Women in Group I (Springfusor® arm) will receive loading and maintenance doses of magnesium sulfate administered via an IV infusion administered with the Springfusor pump, a simple, inexpensive flow-controlled pump system.

Sponsors

Christian Medical College, Vellore, India
CollaboratorOTHER
Chhatrapati Shahuji Maharaj Medical University
CollaboratorOTHER
Government Medical College, Nagpur
CollaboratorINDUSTRY
MacArthur Foundation
CollaboratorOTHER
Gynuity Health Projects
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Exhibit systolic blood pressure \> 140mm Hg OR a diastolic pressure \> 100 mm Hg; * Exhibit proteinuria \> 1+; * Have not given birth, or be 24h or less postpartum; * Exhibit urine output \>100 ml or more during the previous 4h or greater than 25 mL/h; * Agree to comply with study procedures; * Be \> 18 years of age; * Give informed consent for study participation

Exclusion criteria

* Eclamptic or seizing at the time of enrollment * Received magnesium sulfate therapy 24h prior to study enrollment

Design outcomes

Primary

MeasureTime frame
completed course of treatment24 hours postpartum

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026