Clinical trial NCT00666133: Treatment Approaches for Preeclampsia in Low-Resource Settings
Official title: Treatment Approaches for Preeclampsia in Low-Resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Keywords: Preeclampsia
Eclampsia
Magnesium Sulfate
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Christian Medical College, Vellore, India
name: Chhatrapati Shahuji Maharaj Medical University
name: Government Medical College, Nagpur
name: MacArthur Foundation
First posted: 2008-04-24
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: completed course of treatment
timeFrame: 24 hours postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Government Medical College
state: Maharastra
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
Study officials:
affiliation: Gynuity Health Projeccts
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salinger DH, Mundle S, Regi A, Bracken H, Winikoff B, Vicini P, Easterling T. Magnesium sulphate for prevention of eclampsia: are intramuscular and intravenous regimens equivalent? A population pharmacokinetic study. BJOG. 2013 Jun;120(7):894-900. doi: 10.1111/1471-0528.12222. Epub 2013 Mar 26.