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Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia

F

FDA Office of Orphan Products Development

Status

Completed

Conditions

Pre-eclampsia

Treatments

Drug: nimodipine
Drug: magnesium sulfate

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00004399
BCM-FDR001061
UU-FDR001061
199/13249

Details and patient eligibility

About

OBJECTIVES:

I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.

Full description

PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.

Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.

Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria:
  • Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg
  • Proteinuria greater than 5 g/24 hr
  • Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L
  • Severe headache and/or scotomata
  • Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr)
  • Pulmonary edema

--Prior/Concurrent Therapy--

  • No prior/concurrent magnesium sulfate or dihydropyridine agents
  • No other concurrent antiseizure medications

--Patient Characteristics--

  • Age: Not specified
  • Performance status: Not specified
  • Hematopoietic: See Disease Characteristics
  • Hepatic: See Disease Characteristics
  • Renal: No severe renal failure See Disease Characteristics
  • Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics
  • Pulmonary: See Disease Characteristics

--Other:--

  • No severe mental or physical disorder that may affect therapy
  • Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate
  • No evidence of fetal distress or fetal anomalies

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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