Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants experiencing immediate treatment-related adverse events
研究概览
简要总结
Cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. The aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing.
详细描述
Cabergoline is a dopamine receptor agonist. Outside of the United States, it is occasionally used to suppress lactation, most commonly after a pregnancy loss or stillbirth. However, the investigators noted that the patient population in Israel has been requesting cabergoline for administration after healthy births, for immediate lactation suppression.
Use of cabergoline after delivery comes with many concerns. One primary concern is that this medication can increase the risk of venous thrombotic events, particularly during postpartum when thrombosis risk is already elevated. Secondly, it may have effects that alter mood, which are similarly concerning during a vulnerable period when postpartum depression and other mental health disorders are common.
Finally, of course, is the issue that so many women are requesting lactation suppression immediately after birth, and therefore will not accrue the neonatal and maternal benefits of lactation.
The investigators want to understand the characteristics, demographics and other factors that lead these women to make this choice, as well as assess their risk of medical and psychological adverse effects from cabergoline used in the postpartum period.
During this study, the investigators will not be prescribing cabergoline or in any way affecting its use. The study will be recruiting as subjects women who requested and received cabergoline prescriptions independently, as is common practice throughout the country.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum women
- •After a live birth
- •Requesting cabergoline for lactation suppression
排除标准
- •those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss
结局指标
主要结局
Number of participants experiencing immediate treatment-related adverse events
时间窗: immediate postpartum
Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire
Demographics of women requesting cabergoline
时间窗: immediate postpartum
Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire
Number of participants experiencing early treatment-related adverse events
时间窗: 1 week postpartum
Adverse effects experienced by women taking cabergoline within 1 week after treatment will be recorded using questionnaire with focus on thromboembolic events, and depression or mood changes.
Number of participants experiencing late treatment-related adverse events
时间窗: six weeks postpartum
Adverse effects experienced by women taking cabergoline within 6 weeks after treatment, will be recorded using questionnaire, with focus on thromboembolic events, and depression or mood changes.
次要结局
- Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth(immediate postpartum)
研究者
Dr. Sarit Kalfon
Principal Investigator
Laniado Hospital
