Factors and Outcomes Associated With Postpartum Cabergoline Use

• Conditions: Cabergoline Adverse Reaction; Lactation Suppressed; Postpartum Depression; Postpartum DVT

• Registration Number: NCT03965572
• Lead Sponsor: Laniado Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-26
• Study First Posted: 2019-05-29
• Study Start: 2019-06-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing immediate treatment-related adverse events	immediate postpartum	Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire
Demographics of women requesting cabergoline	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth	immediate postpartum	Questionnaire assessing motivations expressed by women requesting cabergoline for lactation suppression postpartum, using questionnaire

Trial Locations

Locations (1)

Laniado Hospital, The Betty Retter Mother & Baby Medical Center; 🇮🇱 Netanya, Israel