Factors and Outcomes Associated With Postpartum Cabergoline Use

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Sarit Kalfon, MD; Phone Number: +972547922182; Email: saritkalfon@gmail.com
• Study Contact Backup: Name: Odelia Shmulevitz, B.Sc, MHA; Phone Number: +972-(0)9-8925248; Email: oshmulevitz@laniado.org.il

Study Locations

• Israel
  • Netanya, Israel
    • Recruiting
    • Laniado Hospital, The Betty Retter Mother & Baby Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

We are studying the demographics, motivations, and outcomes of women who request cabergoline for lactation suppression following a live birth.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Postpartum women who requested cabergoline; A cohort of postpartum women, after a live birth, who request cabergoline for lactation suppression.
Control group; An age-matched cohort of women after a live birth who have not requested cabergoline for lactation suppression.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laniado Hospital
• Investigators: Principal Investigator: Sarit Kalfon, MD, Laniado Hospital

Publications and helpful links

General Publications

• AlSaad D, ElSalem S, Abdulrouf PV, Thomas B, Alsaad T, Ahmed A, AlHail M. A retrospective drug use evaluation of cabergoline for lactation inhibition at a tertiary care teaching hospital in Qatar. Ther Clin Risk Manag. 2016 Feb 9;12:155-60. doi: 10.2147/TCRM.S96298. eCollection 2016.
• Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.
• Ben Natan M, Wiener A, Ben Haim Y. Women׳s intention to exclusively breast feed: The Israeli perspective. Midwifery. 2016 Mar;34:173-177. doi: 10.1016/j.midw.2015.11.013. Epub 2015 Nov 22.
• McGuire TM. Drugs affecting milk supply during lactation. Aust Prescr. 2018 Feb;41(1):7-9. doi: 10.18773/austprescr.2018.002. Epub 2018 Feb 1. No abstract available.
• Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005937. doi: 10.1002/14651858.CD005937.pub3.
• Senat MV, Sentilhes L, Battut A, Benhamou D, Bydlowski S, Chantry A, Deffieux X, Diers F, Doret M, Ducroux-Schouwey C, Fuchs F, Gascoin G, Lebot C, Marcellin L, Plu-Bureau G, Raccah-Tebeka B, Simon E, Breart G, Marpeau L. Postpartum practice: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:1-8. doi: 10.1016/j.ejogrb.2016.04.032. Epub 2016 Apr 29.

Helpful Links

• Interim Report from Ministry of Health
• Breastfeeding basics: lactation suppression

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): May 12, 2023

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 26, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: cabergoline, lactation, suppression, postpartum care
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 0017-19-LND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No