NCT03965572

Factors and Outcomes Associated With Postpartum Cabergoline Use

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Laniado Hospital · Academic / Other
• Sex: Female
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Lactation Suppressed
• Cabergoline Adverse Reaction
• Postpartum DVT
• Postpartum Depression

Timeline

• Start date: 2019-06-07
• Primary completion: 2022-12-31
• Completion: 2023-05-12
• First posted: 2019-05-29
• Last updated: 2021-09-28

Locations

1 site across 1 country: Israel