Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the improvement in nausea and/or vomiting after treatment
研究概览
简要总结
There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.
详细描述
- Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
- After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
- If no improvement is shown, the patient will be treated with the other drug
- The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
- The interview includes medical history and details about their illness, other treatments, hospitalization etc.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women until 12th week of gestation
- •The women visit the ER because of nausea and vomiting
- •The women didn't received thiamine yet
排除标准
- •Pregnant women over 12th week of gestation
- •Women that received thiamine before
- •women that allergic to the studied drugs
研究组 & 干预措施
1. thiamine
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive thiamine IV
干预措施: thiamine & promethazine (Drug)
2. promethazine
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive promethazine IV
干预措施: thiamine & promethazine (Drug)
结局指标
主要结局
the improvement in nausea and/or vomiting after treatment
时间窗: 2 months after first visit in ER (until 14 week of pregnancy)
次要结局
未报告次要终点