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临床试验/NCT03965572
NCT03965572Unknown不适用

Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel

Laniado Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月7日最近更新:
适应症

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

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

发起方
Laniado Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sarit Kalfon

Principal Investigator

Laniado Hospital

研究点 (1)

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