The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte
Varese, Italy
Percentage of mothers who exclusively breastfeed their child
Time frame: At 6 weeks postpartum
Rate of breastfeeding (either exclusively or as a supplement to formula feeding )
Time frame: at 6 weeks and 3 months
Volume (mL) and frequency (times a day) of formula
Time frame: 6 weeks postpartum
weight gain experienced by the newborns
Time frame: 6 weeks postpartum
serum prolactin level
Time frame: at baseline and 6 weeks after treatment
Rate of maternal allergic reactions and gastrointestinal side effects
Time frame: 6 weeks postpartum
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