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OpenTrials
Completed

NCT Number: NCT00666133

Treatment Approaches for Preeclampsia in Low-Resource Settings

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Government Medical College, Nagpur, Maharashtra, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpringFusor Pump

Device

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.

Primary outcomes

  1. completed course of treatment

    Time frame: 24 hours postpartum

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Chhatrapati Shahuji Maharaj Medical University
  • Christian Medical College, Vellore, India
  • Government Medical College, Nagpur
  • MacArthur Foundation

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 24, 2008
Registry last updated
Dec 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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