Treatment Approaches for Preeclampsia in Low-Resource Settings

This study has been completed.
Sponsor:
Collaborators:
Christian Medical College, Vellore, India
Chhatrapati Shahuji Maharaj Medical University
Government Medical College, Nagpur
MacArthur Foundation
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00666133
First received: April 22, 2008
Last updated: December 8, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Preeclampsia
Device: SpringFusor Pump

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Approaches for Preeclampsia in Low-Resource Settings

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • completed course of treatment [ Time Frame: 24 hours postpartum ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 304
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Women in Group II (standard of care) will receive an 8 mL loading dose containing 4g magnesium sulfate administered manually per standard hospital protocol. The solution will be diluted with normal saline according to standard hospital practice, and given IV over 20 minutes. For women in Group II, the IV loading dose will be followed immediately with 20 mL treatment by IM injection, given as 10 mL (5 g magnesium sulfate) into each buttock. This dose will be followed by 10 mL treatments (5g magnesium sulfate) every four hours, injected into alternate buttock. Treatment will be discontinued when clinically indicated.
Experimental: 1
Women in Group I (Springfusor® arm) will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4will be administered using the Springfusor® pump. For women in Group I, the administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. The pump will be started immediately after the initial bolus and the 4g dose repeated (and syringe replaced) every four hours for upto 24 hours postpartum.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666133

Locations
India
Government Medical College
Nagpur, Maharastra, India, 440015
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Sponsors and Collaborators
Gynuity Health Projects
Christian Medical College, Vellore, India
Chhatrapati Shahuji Maharaj Medical University
Government Medical College, Nagpur
MacArthur Foundation
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projeccts
  More Information

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Beverly Winikoff, President, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00666133     History of Changes
Other Study ID Numbers: 4.2.1
Study First Received: April 22, 2008
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Gynuity Health Projects:
Preeclampsia
Eclampsia
Magnesium Sulfate

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 01, 2014