Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Not Applicable

Completed

• Conditions: Lactation Suppressed
• Interventions: Drug: Cabergoline; Drug: Pyridoxine

• Registration Number: NCT05024422
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Study Start: 2021-12-31
• Status Verified: 2022-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-07
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of Cabergoline	Cabergoline	one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days
Administration of Vitamin B6	Pyridoxine	200 mg X 3 per day for a week

Primary Outcome Measures

Name	Time	Method
Lactation suppression	7 days
reduction of congestion	14 days
cessation of breast pain	14 days
cessation of milk leakage	14 days

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel