Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Fenugreek on Milk Production
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 stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant.

The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply.

In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue.

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 in the test group will have increased milk production at the end of the 8-day study.


Options:
A: Inclusion Criteria:

All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria

Exclusion Criteria:

1. Patients who have epilepsy or on anti-seizure medications,
2. Patients who have a history of significant depression or are on antidepressant drugs
3. Patients who have pheochromocytoma or uncontrolled hypertension
4. Patients who have intestinal bleeding or obstruction
5. Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
6. Patients who have diabetes and hyperprolactinaemia
7. Patients with HIV infection
8. Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
B: Inclusion Criteria:

* singleton, term delivery
* \>2.5 kg newborn weight
* lactation-deficiency

Exclusion Criteria:

* Neonatal Intensive Care Unit admission
* use of galactagogue drugs
* allergy
C: Inclusion Criteria:

* 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 Criteria:

* 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:

  1. Diuretics
  2. Pseudoephedrine
  3. Anticholinergics
  4. Warfarin or any anticoagulant
  5. 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
D: Inclusion Criteria:

* age 20 to 45 years at delivery
* received prenatal care in Kaiser Permanente Northern California (KPNC) health care system
* Gestational Diabetes (GDM) pregnancy diagnosed using the 3-hour 100 g OGTT by Carpenter and Coustan criteria
* delivered a singleton, live birth \>= 35 weeks gestation
* no pre-existing diabetes or other serious medical conditions prior to index GDM pregnancy
* no diabetes diagnosis (2-hour 75 gram OGTT) at 6 to 9 weeks postpartum for the index GDM pregnancy
* no use of thyroid medications, steroids, or other medications affecting glucose tolerance
* not planning to move from the northern California area within the subsequent 24 months
* not planning another pregnancy within the next two years
* Two infant feeding groups: women who did not lactate or did so for less than 3 weeks, OR women who provided no supplemental milk feeds at 2-4 weeks and planned to continue intensive lactation defined as \<= 1 formula supplement (6 oz/day) from 6-9 weeks until 4 months or more postpartum.

Exclusion criteria:

* Women who fed both breast milk and 7-16 oz of formula (mixed feeding) during the first 4 weeks of life

Answer: C