Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

NCT05024422 | Completed

• 1 other identifier: 0053-21
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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. 1.Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
2. 2.Administration of Vitamin B6 (200 mg X 3 per day for a week)

Conditions

Lactation Suppressed

Outcome Measures

Primary Outcomes (4)

• Lactation suppression

  7 days

• reduction of congestion

  14 days

• cessation of milk leakage

  14 days

• cessation of breast pain

  14 days

Study Arms (2)

Administration of Cabergoline

ACTIVE COMPARATOR

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

Drug: Cabergoline

Administration of Vitamin B6

ACTIVE COMPARATOR

200 mg X 3 per day for a week

Drug: Pyridoxine

Interventions

Cabergoline DRUG

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

Administration of Cabergoline

Pyridoxine DRUG

Administration of Pyridoxine (200 mg X 3 per day for a week)

Also known as: Vitamin B6

Administration of Vitamin B6

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum women who are interested in pharmacologic lactation suppression
• Women over the age of 18

You may not qualify if:

• Women with known sensitivity to vitamin B6 or Cabergoline
• Women with hypertensive Disorders or contraindication to Cabergoline.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, Israel

Location

Related Publications (1)

• Dayan-Schwartz A, Yefet E, Massalha M, Hosari-Mhameed S, Remer-Gross C, Pasand E, Nachum Z. The efficiency of cabergoline vs pyridoxine for lactation inhibition-a randomized controlled trial. Am J Obstet Gynecol. 2024 May;230(5):561.e1-561.e8. doi: 10.1016/j.ajog.2023.10.009. Epub 2023 Oct 11.

  PMID: 37827268 DERIVED

MeSH Terms

Interventions

Cabergoline; Pyridoxine; Vitamin B 6

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: December 31, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 7, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

IL (1)