Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Study Overview
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Brief Summary
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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: 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) All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.

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

Conditions
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Lactation Suppressed

Intervention / Treatment
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* Drug: Cabergoline
* Drug: Pyridoxine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Administration of Cabergoline<br>one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days | Drug: Cabergoline<br>* Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)<br>|
| Active Comparator: Administration of Vitamin B6<br>200 mg X 3 per day for a week | Drug: Pyridoxine<br>* Administration of Pyridoxine (200 mg X 3 per day for a week)<br>* Other names: Vitamin B6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactation suppression |  | 7 days | 
| reduction of congestion |  | 14 days | 
| cessation of milk leakage |  | 14 days | 
| cessation of breast pain |  | 14 days |