Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Lactation Suppressed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024422
• Other study ID #: 0053-21
• Status: Completed
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: November 7, 2022

Study information

• Verified date: November 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 7, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lactation Suppressed

Intervention

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

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactation suppression		7 days
Primary	reduction of congestion		14 days
Primary	cessation of milk leakage		14 days
Primary	cessation of breast pain		14 days