Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Overview

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.

Full Title of Study: “Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2022

Interventions

  • Drug: Cabergoline
    • Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
  • Drug: Pyridoxine
    • Administration of Pyridoxine (200 mg X 3 per day for a week)

Arms, Groups and Cohorts

  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • Lactation suppression
    • Time Frame: 7 days
  • reduction of congestion
    • Time Frame: 14 days
  • cessation of milk leakage
    • Time Frame: 14 days
  • cessation of breast pain
    • Time Frame: 14 days

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Adi Dayan Schwartz, MD, 046495483, adi_da@clalit.org.il

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