MgSO4 vs Metoclopramide for Headache in Pregnant Women (MagHead)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Ghada Bourjeily, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00632606
First received: February 29, 2008
Last updated: December 21, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632606

Locations
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
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 July 29, 2014