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临床试验/NCT05024422
NCT05024422已完成不适用

Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年12月31日最近更新:
适应症
干预措施

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:

  1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
  2. 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

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

Active Comparator

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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