Factors and Outcomes Associated With Postpartum Cabergoline Use

NCT03965572 | Unknown

• 1 other identifier: 0017-19-LND
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactation Suppressed; Cabergoline Adverse Reaction; Postpartum DVT; Postpartum Depression

Keywords

cabergoline, lactation, suppression, postpartum care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth

  immediate postpartum

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Postpartum women
• After a live birth
• Requesting cabergoline for lactation suppression

You may not qualify if:

• those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss

Sponsors & Collaborators

• Laniado Hospital: lead

Study Sites (1)

Laniado Hospital, The Betty Retter Mother & Baby Medical Center

Netanya, Israel

RECRUITING

Related 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.

  PMID: 26929627 BACKGROUND

• 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.

  PMID: 22946888 BACKGROUND

• 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.

  PMID: 26652854 BACKGROUND

• 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.

  PMID: 29507453 BACKGROUND

• 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.

  PMID: 22972088 BACKGROUND

• 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.

  PMID: 27155443 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Depression, Postpartum; Breast Feeding

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior; Behavior

Study Officials

• Sarit Kalfon, MD

  Laniado Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarit Kalfon, MD

CONTACT

+972547922182; saritkalfon@gmail.com

Odelia Shmulevitz, B.Sc, MHA

CONTACT

+972-(0)9-8925248; oshmulevitz@laniado.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 29, 2019
• Study Start: June 7, 2019
• Primary Completion: December 31, 2022
• Study Completion: May 12, 2023
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)