Status:
TERMINATED
Effect of Fenugreek on Milk Production
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Lactation
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stop...
Detailed Description
This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled i...
Eligibility Criteria
Inclusion
- Mothers 2-12 weeks postpartum
- Mothers with term infants 37 weeks gestation or older
- Mothers with poor milk supply documented by professional lactation consultants
- Mothers whose milk supply is less than 600 cc per 24 hours
- Mothers who agree not to breastfeed or provide their milk to their infants during this study
Exclusion
- Mothers with documented mastitis
- Mothers with breast engorgement
- Mothers with inverted nipples
- Maternal BMI greater than 35
- Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production
- Mothers who are clinically ill or hospitalized, or taking the following medications:
- Diuretics
- Pseudoephedrine
- Anticholinergics
- Warfarin or any anticoagulant
- An estrogen-containing birth control pill
- Mothers with Diabetes mellitus
- Mothers who have had breast surgery that could alter milk synthesis or production
- Mothers diagnosed with Polycystic ovary syndrome
- Mothers with tubular breasts or breasts with insufficient glandular tissue
- Mothers diagnosed with Asthma or atopic disease
- Mothers who are known to be allergic to peanuts or soybeans
- Mothers who are pregnant
- Mothers whose milk supply per 24 hours exceeds 600 mL
- Mothers with Obstetrical evaluation recommending exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00851591
Start Date
September 1 2008
End Date
August 1 2012
Last Update
June 26 2018
Active Locations (1)
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1
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106