MgSO4 vs Metoclopramide for Headache in Pregnant Women

• Status: Withdrawn
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women and Infants Hospital of Rhode Island
• Treatments: Acetaminophen; Magnesium Sulfate; Metoclopramide

Criteria

Inclusion Criteria:

• Pregnant, 18-75

• Headache rated 4 or greater on a 0-10 pain scale

Exclusion Criteria:

• New objective neurologic abnormality at the time of exam

• Temperature >100.4

• Allergy or intolerance to study medications

• Suspected of confirmed preeclampsia/eclampsia

• Complete heart block

• Hypotension, SBP<85

• Myasthenia gravis

• End stage renal failure