Clinical trial NCT03965572: Factors and Outcomes Associated With Postpartum Cabergoline Use
Official title: Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lactation Suppressed
Cabergoline Adverse Reaction
Postpartum DVT
Postpartum Depression
Keywords: cabergoline, lactation, suppression, postpartum care
Lead sponsor: Laniado Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographics of women requesting cabergoline
timeFrame: immediate postpartum
measure: Number of participants experiencing immediate treatment-related adverse events
timeFrame: immediate postpartum
measure: Number of participants experiencing early treatment-related adverse events
timeFrame: 1 week postpartum
measure: Number of participants experiencing late treatment-related adverse events
timeFrame: six weeks postpartum
Secondary outcomes:
measure: Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth
timeFrame: immediate postpartum
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Laniado Hospital, The Betty Retter Mother & Baby Medical Center
Study officials:
affiliation: Laniado Hospital
name: Sarit Kalfon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.
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.
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. No abstract available.
citation: 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.
citation: 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.