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Factors and Outcomes Associated With Postpartum Cabergoline Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965572
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Sarit Kalfon, Laniado Hospital

Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 29, 2019
Last Update Posted Date February 21, 2020
Actual Study Start Date June 7, 2019
Estimated Primary Completion Date May 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2019)
  • Demographics of women requesting cabergoline [ Time Frame: immediate postpartum ]
    Demographics parameter of women requesting cabergoline- age, number of children, profession. Data will be collected using questionnaire
  • Number of participants experiencing immediate treatment-related adverse events [ Time Frame: immediate postpartum ]
    Adverse effects experienced by women taking cabergoline within few days after treatment will be recorded using questionnaire
  • Number of participants experiencing early treatment-related adverse events [ Time Frame: 1 week postpartum ]
    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.
  • Number of participants experiencing late treatment-related adverse events [ Time Frame: six weeks postpartum ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2019)
Motivations conducting participants to ask for a lactation suppression drug immediatly after giving birth [ Time Frame: immediate postpartum ]
Questionnaire assessing motivations expressed by women requesting cabergoline for lactation suppression postpartum, using questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors and Outcomes Associated With Postpartum Cabergoline Use
Official Title Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Lactation Suppressed
  • Cabergoline Adverse Reaction
  • Postpartum DVT
  • Postpartum Depression
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 26, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 12, 2023
Estimated Primary Completion Date May 12, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sarit Kalfon, MD +972547922182 saritkalfon@gmail.com
Contact: Odelia Shmulevitz, B.Sc, MHA +972-(0)9-8925248 oshmulevitz@laniado.org.il
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03965572
Other Study ID Numbers 0017-19-LND
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Sarit Kalfon, Laniado Hospital
Study Sponsor Laniado Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Sarit Kalfon, MD Laniado Hospital
PRS Account Laniado Hospital
Verification Date February 2020