MgSO4 vs Metoclopramide for Headache in Pregnant Women (MagHead)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Headache |
Drug: magnesium sulfate Drug: metoclopramide |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: magnesium sulfate
|
|
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 Name: Reglan
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| Principal Investigator: | Meghan Hayes, MD | Women and Infants Hospital of Rhode Island |
More Information
No publications provided
| Responsible Party: | Ghada Bourjeily, Dr. Ghada Bourheily, Women and Infants Hospital of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT00632606 History of Changes |
| Other Study ID Numbers: | IRB#08-0006 |
| Study First Received: | February 29, 2008 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Women and Infants Hospital of Rhode Island:
|
pregnant women |
Additional relevant MeSH terms:
|
Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetaminophen Magnesium Sulfate Metoclopramide Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents Antiemetics Autonomic Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013