Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Lactation suppression
研究概览
简要总结
Some mothers may seek lactation suppression on personal, social, or medical grounds. To reduce congestion symptoms and shorten the duration of milk production lactation suppression can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems or liver disease. Vitamin B6 has also been studied for this indication with no significant side effects. All those studies conducted before 1980. There is no current literature on the subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication.
Purpose:
The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for lactation suppression.
method: A prospective randomized study in the maternity ward at Haemek medical center in Afula, Israel.
Postpartum women without contraindication to any one of the treatments, who are interested in a pharmaceutical induced lactation suppression will be divided into two randomized groups:
- Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
- Administration of Vitamin B6 (200 mg X 3 per day for a week)
All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum women who are interested in pharmacologic lactation suppression
- •Women over the age of 18
排除标准
- •Women with known sensitivity to vitamin B6 or Cabergoline
- •Women with hypertensive Disorders or contraindication to Cabergoline.
研究组 & 干预措施
Administration of Cabergoline
one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days
干预措施: Cabergoline (Drug)
Administration of Vitamin B6
200 mg X 3 per day for a week
干预措施: Pyridoxine (Drug)
结局指标
主要结局
Lactation suppression
时间窗: 7 days
reduction of congestion
时间窗: 14 days
cessation of breast pain
时间窗: 14 days
cessation of milk leakage
时间窗: 14 days
次要结局
未报告次要终点
