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Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05024422
Collaborator
(none)
97
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Some mothers may seek lactation suppression on personal, social, or medical grounds. To reduce congestion symptoms and shorten the duration of milk production lactation suppression can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems or liver disease. Vitamin B6 has also been studied for this indication with no significant side effects. All those studies conducted before 1980. There is no current literature on the subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication.

Purpose:

The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for lactation suppression.

method: A prospective randomized study in the maternity ward at Haemek medical center in Afula, Israel.

Postpartum women without contraindication to any one of the treatments, who are interested in a pharmaceutical induced lactation suppression will be divided into two randomized groups:

  1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)

  2. Administration of Vitamin B6 (200 mg X 3 per day for a week)

All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Administration of Cabergoline

one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days

Drug: Cabergoline
Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
Active Comparator: Administration of Vitamin B6

200 mg X 3 per day for a week

Drug: Pyridoxine
Administration of Pyridoxine (200 mg X 3 per day for a week)
Other Names:
  • Vitamin B6

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lactation suppression [7 days]

    2. reduction of congestion [14 days]

    3. cessation of milk leakage [14 days]

    4. cessation of breast pain [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Postpartum women who are interested in pharmacologic lactation suppression

    2. Women over the age of 18

    Exclusion Criteria:

    1. Women with known sensitivity to vitamin B6 or Cabergoline

    2. Women with hypertensive Disorders or contraindication to Cabergoline.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HaEmek Medical Center Afula Israel

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT05024422
    Other Study ID Numbers:
    • 0053-21
    First Posted:
    Aug 27, 2021
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pyridoxine
    Vitamin B 6
    Cabergoline

    Study Results

    No Results Posted as of Aug 27, 2021