Lactation Suppressed
Conditions
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.
Interventions
DRUGCabergoline
Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
DRUGPyridoxine
Administration of Pyridoxine (200 mg X 3 per day for a week)
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lactation suppression | 7 days |
| reduction of congestion | 14 days |
| cessation of milk leakage | 14 days |
| cessation of breast pain | 14 days |
Countries
Israel
Outcome results
None listed