跳至主要内容
临床试验/NCT01668069
NCT01668069已完成不适用

Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy

United States Naval Medical Center, San Diego1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Reduction of nausea on the VAS (Visual Analog Scale)

研究概览

简要总结

Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are using ondansetron as first line in practice. Despite this practice and the recommendations from ACOG, there is not data to suggest that ether practice is superior. This will be the first prospective, randomized, double blind, controlled trial comparing the two treatments. We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely benefit from less Emergency Department visits, urgent clinic visits, and admissions for progression to hyperemesis gravidarum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are less than 16 weeks pregnant by last menstrual period or ultrasound
  • Greater than 18 years of age
  • English speaking
  • No significant visual or hearing impairment
  • Requesting treatment for nausea associated with pregnancy

排除标准

  • If nausea or vomiting preexisted the pregnancy
  • Requires hospitalization at the time of initial enrollment
  • Already taking anti-emetics to include metoclopramide, ondansetron, doxylamine, pyridoxine, or promethazine
  • The patient has an allergy to either study regimen
  • If they are unable to return for a follow up visit in 1 week

研究组 & 干预措施

Ondansetron

Experimental

study drug

干预措施: Ondansetron (Drug)

结局指标

主要结局

Reduction of nausea on the VAS (Visual Analog Scale)

时间窗: 5 days

次要结局

  • Reduction in vomiting on the VAS(5 days)
  • Any adverse effects caused by the study medications.(5 days)

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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