MgSO4 vs Metoclopramide for Headache in Pregnant Women (MagHead)

Magnesium Sulfate vs Metoclopramide for Headache in Pregnant Women

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.

Study Overview

• Status: Withdrawn
• Conditions: Headache
• Intervention / Treatment: Drug: magnesium sulfate; Drug: metoclopramide

Detailed Description

Metoclopramide and prochlorperazine (Compazine®), antiemetic dopamine receptor antagonists, are widely used for headache treatment in North American emergency departments. Metoclopramide, FDA pregnancy category B, is used in clinical practice for acute headache in pregnant women. Small studies have found magnesium sulfate to be effective in migraine, tension and cluster headaches, although there is no data regarding efficacy or tolerability in pregnant women.

Our study would be similar to a Turkish study published in 2004 which compared magnesium sulfate to metoclopramide for acute headache treatment in nonpregnant individuals; they found the drugs equally effective 30 minutes after administration. Serum magnesium levels in pregnant women are often lower than in nonpregnant women; magnesium deficiency has been explored as contributing to headache frequency and severity. Magnesium sulfate use has been well established during pregnancy for decades, administered intravenously to delay labor or to women with preeclampsia for 24 to 48 hours, initially with 4 to 6 gram bolus then 2 grams per hour. For headache treatment, magnesium sulfate dose would be far lower, 2 grams. We would like to determine the efficacy and tolerability of magnesium sulfate for headache relief in pregnant women, as well as evaluate efficacy of metoclopramide in pregnant women. We do not find published randomized trials evaluating headache treatment in pregnant women.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; magnesium sulfate 2 grams intravenously w/ acetaminophen 1 gram orally	Drug: magnesium sulfate; magnesium sulfate 2 grams intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally
Active Comparator: Arm 2; metoclopramide 10 mg intravenously w/ 1 gram acetominophen orally	Drug: metoclopramide; metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally; Other Names: Reglan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous metoclopramide (Reglan®) for acute headache in pregnant women.	1 year

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Meghan Hayes, MD, Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 11, 2008

Study Record Updates

• Last Update Posted (Estimate): December 25, 2012
• Last Update Submitted That Met QC Criteria: December 21, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: pregnant women
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Membrane Transport Modulators; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate; Metoclopramide
• Other Study ID Numbers: IRB#08-0006