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临床试验/NCT00632606
NCT00632606撤回2 期

Magnesium Sulfate vs Metoclopramide for Headache in Pregnant Women

Women and Infants Hospital of Rhode Island1 个研究点 分布在 1 个国家开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
发起方
试验地点
1
主要终点
The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous metoclopramide (Reglan®) for acute headache in pregnant women.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Arm 1

Active Comparator

magnesium sulfate 2 grams intravenously w/ acetaminophen 1 gram orally

干预措施: magnesium sulfate (Drug)

Arm 2

Active Comparator

metoclopramide 10 mg intravenously w/ 1 gram acetominophen orally

干预措施: metoclopramide (Drug)

结局指标

主要结局

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

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Bourjeily

Dr. Ghada Bourheily

Women and Infants Hospital of Rhode Island

研究点 (1)

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