Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- breast symptoms
研究概览
简要总结
The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.
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
- Single (Participant)
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
- •pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises
- •ages 18 to 50
- •con provide informed consent in English
排除标准
- •Age under 18 or above 50
- •gestational ages before 16 weeks 0 days or after 20 weeks 0 days
- •unable to provide written consent in English
- •hypertensive disorder
- •uncontrolled hypertension or known hypersensitivity to ergot derivatives
- •History of cardiac valvular disorders
- •history of pulmonary fibrosis
- •documented bipolar schizophrenia
- •documented allergy to medication, including lactose intolerance (placebo pill involves lactose)
研究组 & 干预措施
Cabergoline
1mg oral cabergoline administered once after patient's procedure
干预措施: Cabergoline (Drug)
Placebo
1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure
干预措施: Placebo (Drug)
结局指标
主要结局
breast symptoms
时间窗: 3 days post procedure and two weeks post procedure
Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).
次要结局
未报告次要终点