Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Lactation Suppressed
• Intervention / Treatment: Drug: Cabergoline; Drug: Pyridoxine

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lactation suppression	7 days
reduction of congestion	14 days
cessation of milk leakage	14 days
cessation of breast pain	14 days

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Micronutrients; Dopamine Agonists; Dopamine Agents; Vitamins; Vitamin B Complex; Antiparkinson Agents; Anti-Dyskinesia Agents; Vitamin B 6; Pyridoxine; Cabergoline
• Other Study ID Numbers: 0053-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No