Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

NCT ID: NCT05024422

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2022-11-07

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.

Conditions

Lactation Suppressed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of Cabergoline

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

Group Type: ACTIVE_COMPARATOR

Cabergoline

Intervention Type: 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 Vitamin B6

200 mg X 3 per day for a week

Group Type: ACTIVE_COMPARATOR

Pyridoxine

Intervention Type: DRUG

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

Interventions

Cabergoline

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

Intervention Type: DRUG

Pyridoxine

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

Intervention Type: DRUG

Other Intervention Names

Vitamin B6

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HaEmek Medical Center

Afula, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 37827268 (View on PubMed)

Other Identifiers

0053-21

Identifier Type: -

Identifier Source: org_study_id