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Completed

NCT Number: NCT05024422

Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek Medical Center

Afula, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

cabergoline

Drug

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

Pyridoxine

Drug

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

Other names: Vitamin B6

Primary outcomes

  1. Lactation suppression

    Time frame: 7 days

  2. reduction of congestion

    Time frame: 14 days

  3. cessation of milk leakage

    Time frame: 14 days

  4. cessation of breast pain

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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