drugset / Trial / NCT00632606

MgSO4 vs Metoclopramide for Headache in Pregnant Women

NCT00632606

RandomizedCrossoverTriple-blindTreatment

Summary

The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous metoclopramide (Reglan®) for acute headache in pregnant women. We will randomize pregnant women who present to our emergency department with chief complaint of headache to magnesium sulfate 2 grams intravenously or metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally and normal saline 1 liter intravenously. Headaches are common during pregnancy, related to hormonal changes, altered sleep patterns and psychosocial stressors. Common medications for headache such as non-steroidal antiinflammatories or triptans are typically avoided during pregnancy due to concern for fetal effects. Women, and their physicians, are often uncertain regarding available medication options with justifiable safety profiles during pregnancy.

Timeline

Start
2008-08
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Magnesium Sulfate Other / unclassified 2 g Intravenous
Comparator Metoclopramide Small molecule 10 mg Intravenous

Indications