Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

HaEmek Medical Center, Israel

Status: Completed

Conditions: Lactation Suppressed

Treatments: Drug: Pyridoxine; Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT05024422

0053-21

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Administration of Cabergoline

Active Comparator group

Description:

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

Treatment:

Drug: Cabergoline

Administration of Vitamin B6

Active Comparator group

Description:

200 mg X 3 per day for a week

Treatment:

Drug: Pyridoxine