Factors and Outcomes Associated With Postpartum Cabergoline Use

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965572
• Other study ID #: 0017-19-LND
• Status: Recruiting
• Start date: June 7, 2019
• Est. completion date: May 12, 2023

Study information

• Verified date: September 2021
• Source: Laniado Hospital
• Contact: Sarit Kalfon, MD
• Phone: +972547922182
• Email: saritkalfon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 12, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Laniado Hospital, The Betty Retter Mother & Baby Medical Center	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Laniado Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Epub 2012 Sep 4. — View Citation

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. Review. — View Citation

Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD005937. doi: 10.1002/14651858.CD005937.pub3. Review. — View Citation

Sénat 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, Bréart 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics of women requesting cabergoline	Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire	immediate postpartum
Primary	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
Primary	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
Primary	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	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

External Links

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