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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Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, United States, 79106