Factors and Outcomes Associated With Postpartum Cabergoline Use
NCT ID: NCT03965572
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-06-07
2023-05-12
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Postpartum women who requested cabergoline
A cohort of postpartum women, after a live birth, who request cabergoline for lactation suppression.
No interventions assigned to this group
Control group
An age-matched cohort of women after a live birth who have not requested cabergoline for lactation suppression.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* After a live birth
* Requesting cabergoline for lactation suppression
Exclusion Criteria
16 Years
65 Years
FEMALE
Yes
Sponsors
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Laniado Hospital
OTHER
Responsible Party
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Dr. Sarit Kalfon
Principal Investigator
Principal Investigators
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Sarit Kalfon, MD
Role: PRINCIPAL_INVESTIGATOR
Laniado Hospital
Locations
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Laniado Hospital, The Betty Retter Mother & Baby Medical Center
Netanya, , Israel
Countries
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Central Contacts
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Facility Contacts
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Weisbrod, Dr.
Role: primary
References
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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.
Related Links
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Interim Report from Ministry of Health
Breastfeeding basics: lactation suppression
Other Identifiers
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0017-19-LND
Identifier Type: -
Identifier Source: org_study_id
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