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MgSO4 vs Metoclopramide for Headache in Pregnant Women

NCT ID: NCT00632606

Last Updated: 2012-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Headache

Keywords

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pregnant women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

magnesium sulfate 2 grams intravenously w/ acetaminophen 1 gram orally

Group Type ACTIVE_COMPARATOR

magnesium sulfate

Intervention Type DRUG

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

Arm 2

metoclopramide 10 mg intravenously w/ 1 gram acetominophen orally

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

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

Interventions

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magnesium sulfate

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

Intervention Type DRUG

metoclopramide

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

Intervention Type DRUG

Other Intervention Names

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Reglan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Ghada Bourjeily

Dr. Ghada Bourheily

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meghan Hayes, MD

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital of Rhode Island

Locations

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Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#08-0006

Identifier Type: -

Identifier Source: org_study_id