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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Cabergoline | Active Comparator | one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days |
|
| Administration of Vitamin B6 | Active Comparator | 200 mg X 3 per day for a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline | Drug | Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HaEmek Medical Center | Afula | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37827268 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| D011736 | Pyridoxine |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Pyridoxine | Drug | Administration of Pyridoxine (200 mg X 3 per day for a week) |
|
|
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |