MgSO4 vs Metoclopramide for Headache in Pregnant Women

NCT00632606 | Withdrawn Phase 2

• 1 other identifier: IRB#08-0006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache

Keywords

pregnant women

Outcome Measures

Primary Outcomes (1)

• The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous metoclopramide (Reglan®) for acute headache in pregnant women.

  1 year

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

magnesium sulfate 2 grams intravenously w/ acetaminophen 1 gram orally

Drug: magnesium sulfate

Arm 2

ACTIVE COMPARATOR

metoclopramide 10 mg intravenously w/ 1 gram acetominophen orally

Drug: metoclopramide

Interventions

magnesium sulfate DRUG

magnesium sulfate 2 grams intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally

Arm 1

metoclopramide DRUG

metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally

Also known as: Reglan

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant, 18-75
• Headache rated 4 or greater on a 0-10 pain scale

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Magnesium Sulfate; Metoclopramide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Meghan Hayes, MD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ghada Bourheily

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 25, 2012

Record last verified: 2012-12

Locations

US (1)