Treatment Approaches for Preeclampsia in Low-Resource Settings

Preeclampsia Clinical Trial

Official title:

Treatment Approaches for Preeclampsia in Low-Resource Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666133
• Other study ID #: 4.2.1
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: December 8, 2009
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
India	Government Medical College	Nagpur	Maharastra
India	Christian Medical College	Vellore	Tamil Nadu

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Chhatrapati Shahuji Maharaj Medical University, Christian Medical College, Vellore, India, Government Medical College, Nagpur, MacArthur Foundation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completed course of treatment		24 hours postpartum	Yes