NCT00666133

Treatment Approaches for Preeclampsia in Low-Resource Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DEVICE	SpringFusor 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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-04-24
• Last updated: 2009-12-09

Locations

2 sites across 1 country: India