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

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Contacts

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

Locations

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

• Principal Investigator: Ronella Marom, MD; Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

More Information

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT02384655
• Other Study ID Numbers: 0652-14-TLV-RM
• First Posted: March 10, 2015
• 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:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Fenugreek seed meal; Hypoglycemic Agents; Physiological Effects of Drugs