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Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content

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ClinicalTrials.gov Identifier: NCT02384655
Recruitment Status : Unknown
Verified June 2020 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : March 10, 2015
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
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Brief Summary:

Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal intensive care unit acquired morbidity such as NEC and the late onset sepsis.

It is often difficult to obtain sufficient quantities of human milk from mothers of preterm infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use galactogogues in an attempt to increase milk production. Fenugreek (Trigonella foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the pea family. Our experience at the NICU is that around 30% of preterm mothers desperately looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe) as food supplement. Although widely recommended, there is limited evidence to support the effectiveness of fenugreek as a galactogogue.

The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has any effect on macronutrients composition of breast milk and whether fenugreek is transferred to the infant via mother milk. In addition any changes in mother and infant health status will be assessed.


Condition or disease Intervention/treatment Phase
Preterms Lactation Drug: Fenugreek seed meal Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
Actual Study Start Date : March 11, 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fenugreek

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fenugreek
Mothers will take fenugreek for 14 days
 Drug: Fenugreek seed meal
3x3 capsules of fenugreek seeds per day for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Change in daily volume of expressed milk [ Time Frame: at day 0, 3, 7, 10, 14 ]

Secondary Outcome Measures :
  1. Change in Macronutrient content analysis of breastmilk [ Time Frame: at day 0, 3, 7, 14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy mothers 7 to 14 days postpartum,
  • Mothers of preterm infants under 38 weeks of gestation,
  • Mothers with poor milk supply documented by professional lactation consultants.

Exclusion Criteria:

  • Mothers with mastitis,
  • Mothers with breast engorgement,
  • Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production,
  • Mothers who are taking 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 diagnosed with Asthma or atopic disease,
  • Mothers who are known to be allergic to peanuts or soybeans,
  • Mothers whose milk supply per 24 hours exceeds 600 mL,
  • Mothers with hypo/hyperthyroidism
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384655


Contacts
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Contact: Ronella Marom, MD +97236925690 ronellam@tlvmc.gov.il

Locations
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Israel
Department of Neonatology Tel Aviv Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Ronella Marom, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Ronella Marom, MD Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
More Information
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02384655    
Other Study ID Numbers: 0652-14-TLV-RM
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Tel-Aviv Sourasky Medical Center:
Preterms
Breastfeeding
Lactation
Macronutrients
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Fenugreek seed meal
Hypoglycemic Agents
Physiological Effects of Drugs