An observational study in Lactation Suppressed, Cabergoline Adverse Reaction and Postpartum DVT, sponsored by Laniado Hospital. Status unknown at 1 site in Israel. Open to female participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Laniado Hospital · Observational
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.
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 100 is below the median of 223 across 100 observational studies indexed under Depression, Postpartum.
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We are studying the demographics, motivations, and outcomes of women who request cabergoline for lactation suppression following a live birth.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A cohort of postpartum women, after a live birth, who request cabergoline for lactation suppression.
An age-matched cohort of women after a live birth who have not requested cabergoline for lactation suppression.
Demographics of women requesting cabergoline
Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: six weeks postpartum
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
Time frame: immediate postpartum
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Laniado Hospital