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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

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.

Condition or disease
Lactation Suppressed Cabergoline Adverse Reaction Postpartum DVT Postpartum Depression

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Factors and Outcomes Associated With Use of Cabergoline Among Postpartum Women in Israel
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : May 12, 2021
Estimated Study Completion Date : May 12, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965572


Contacts
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Contact: Sarit Kalfon, MD +972547922182 saritkalfon@gmail.com
Contact: Odelia Shmulevitz, B.Sc, MHA +972-(0)9-8925248 oshmulevitz@laniado.org.il

Locations
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Israel
Laniado Hospital, The Betty Retter Mother & Baby Medical Center Recruiting
Netanya, Israel
Contact: Weisbrod, Dr.    972-9-8604601      
Sponsors and Collaborators
Laniado Hospital
Investigators
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Principal Investigator: Sarit Kalfon, MD Laniado Hospital
Additional Information:
Publications:
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Responsible Party: Dr. Sarit Kalfon, Principal Investigator, Laniado Hospital
ClinicalTrials.gov Identifier: NCT03965572    
Other Study ID Numbers: 0017-19-LND
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Dr. Sarit Kalfon, Laniado Hospital:
cabergoline, lactation, suppression, postpartum care
Additional relevant MeSH terms:
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Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders