Factors and Outcomes Associated With Postpartum Cabergoline Use

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The study will involve three questionnaires with these subjects: one in the hospital, after birth; one a week after birth; and one 6 weeks after birth. The questionnaires will involve medical history, a validated lactation questionnaire, as well as demographic data. All data will be held in a private, password-locked database.

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

Conditions
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Lactation Suppressed, Cabergoline Adverse Reaction, Postpartum DVT, Postpartum Depression

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postpartum women After a live birth Requesting cabergoline for lactation suppression Exclusion Criteria: those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postpartum women who requested cabergoline<br>A cohort of postpartum women, after a live birth, who request cabergoline for lactation suppression. | |
| Control group<br>An age-matched cohort of women after a live birth who have not requested cabergoline for lactation suppression. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics of women requesting cabergoline | Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire | immediate postpartum | 
| Number of participants experiencing immediate treatment-related adverse events | Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire | immediate postpartum | 
| Number of participants experiencing early treatment-related adverse events | 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. | 1 week postpartum | 
| Number of participants experiencing late treatment-related adverse events | 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. | six weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth | Questionnaire assessing motivations expressed by women requesting cabergoline for lactation suppression postpartum, using questionnaire | immediate postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cabergoline, lactation, suppression, postpartum care