Factors and Outcomes Associated With Postpartum Cabergoline Use
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|ClinicalTrials.gov Identifier: NCT03965572|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : February 21, 2020
|Condition or disease|
|Lactation Suppressed Cabergoline Adverse Reaction Postpartum DVT Postpartum Depression|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel|
|Actual Study Start Date :||June 7, 2019|
|Estimated Primary Completion Date :||May 12, 2021|
|Estimated Study Completion Date :||May 12, 2023|
Postpartum women who requested cabergoline
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 [ Time Frame: immediate postpartum ]Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire
- Number of participants experiencing immediate treatment-related adverse events [ Time Frame: immediate postpartum ]Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire
- Number of participants experiencing early treatment-related adverse events [ Time Frame: 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 [ Time Frame: 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.
- Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth [ Time Frame: immediate postpartum ]Questionnaire assessing motivations expressed by women requesting cabergoline for lactation suppression postpartum, using questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965572
|Contact: Sarit Kalfon, MDfirstname.lastname@example.org|
|Contact: Odelia Shmulevitz, B.Sc, MHA||+972-(0)email@example.com|
|Laniado Hospital, The Betty Retter Mother & Baby Medical Center||Recruiting|
|Contact: Weisbrod, Dr. 972-9-8604601|
|Principal Investigator:||Sarit Kalfon, MD||Laniado Hospital|