Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
Brief Summary: The overall aims of this project are to 1) determine the quality of life effects of a combination herbal galactagogue tea in lactating women, and 2) measure changes in maternal blood concentration of oxytocin, prolactin, and milk production. The defined outcome measures will include quality of life measures in the breastfeeding woman and basic infant health. If the tea proves safe and effective, then it can provide a proven all-natural and organic supplement for increasing lactation in women. This in turn will increase quality of life for both the infant and the mother.


Options:
A: Inclusion Criteria:

* Women between the ages of 18 and 45 years
* Good general health
* Lactating
* Singleton birth
* Two to twelve weeks postpartum
* Have a full term (\>37 weeks gestation) healthy infant
* Is successfully fully breastfeeding at the time they enter the study
* Intend to fully breastfeed their infants for the following 4 weeks at the time of enrollment.

Exclusion Criteria:

* Chronic illnesses (e.g. diabetes, hypertension, bronchial asthma, Gastroesophageal Reflux Disease (GERD), atopic dermatitis, celiac disease or gluten sensitivity, Crohn's Disease, ulcerative colitis, eating disorders, breast cancer, blood disorder, psychiatric)
* Pre-pregnant BMI (\>50)
* History of alcohol, drug abuse or cigarette smoking
* Currently using the following pharmaceuticals: diuretics, pseudoephedrine, anticholinergics, and an estrogen-containing birth control pill or using an estrogen-containing device
* Currently consuming other drugs/herbals used to induce milk production including metoclopramide, domperidone, or other drugs/herbals (i.e. fenugreek capsules, goat's rue products, or "More Milk" capsules or tinctures)
* Sensitivity or known allergies to peanuts, soybeans, or chick peas
* Sensitivity or known allergies to plants in the Apiaceae/carrot plant family (e.g. anise, celery, coriander, fennel) or the compound anethole
* Sensitivity or known allergies to plants in the Asteraceae/daisy family (e.g. blessed thistle, echinacea, or calendula)
* Taking a selective serotonin reuptake inhibitor (SSRI)
B: Inclusion Criteria among mother-infant dyads:

Stage 1 Criteria (for participation in baseline measurement phase):

* identified with low milk supply by a Cincinnati-area IBCLC
* mother denies obvious cause of low milk supply such as pituitary disorder, breast surgery, severe lack of breast emptying (\< 4 times per day), or failure to show any signs of lactogenesis
* mother at least 20 years of age
* infant is between 1 week and 2 calendar months old
* mother gave birth to a single, healthy, term (\>37 weeks gestation) infant
* mother free of breast and nipple infections
* mother lives within study catchment area
* mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
* mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during follow up measurements (2-4 weeks) as was consumed during the baseline measurements
* mother not currently taking a prescription medication that may affect the hormones of lactation and not planning to initiate any such drug for at least the next 2-4 weeks.
* mother has established pediatric care for the infant

Stage 2 maternal inclusion criteria (among those who meet Stage 1 criteria, to continue with enrollment into randomized controlled trial, goal, N=30 with replacement for non-completers to at least two weeks):

* successful completion of baseline measurements (involving 24-hour test weighing of milk output and undergoing baseline measurements at the clinical research center, including providing fasting blood samples)
* body mass index is \>19.0 kg/m2 (i.e., not underweight)
* evidence of likely insulin resistance, based on at least one of the following: mean fasting plasma glucose between 95.0 - 125.0 g/dL, inclusive; abdominal obesity; history of polycystic ovary syndrome; or history of gestational diabetes
* estimated glomerular filtration rate \> 60 mL/min
* liver function in normal range (AST \<= 37 U/L, ALT \< 87 U/L, and total bilirubin \<= 1.1 mg/dL
* willingness to continue trying to lactate for the next 2-4 weeks
* health history does not reveal illness/treatments for which metformin is contraindicated
* participant is not currently being treated with metformin

Eligibility criteria for enrollment into abundant milk supply comparison group (goal, N=30, will be compared in baseline measurements).

Inclusion criteria:

* exclusively feeding mother's own milk to infant, and presenting to Cincinnati area IBCLC with breastfeeding question or problem unrelated to milk supply
* mother at least 20 years of age
* infant is between 1 week and 2 calendar months old
* mother gave birth to a single, term infant
* mother free of breast and nipple infections
* mother lives within study catchment area
* mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
* mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during baseline measurements
* mother willing to avoid prescription medication that may affect the hormones of lactation
C: Inclusion Criteria:

Women

* healthy women
* inadequate milk supply
* read/speak English

Infants

* healthy term infants (≥ 38 weeks gestational age)
* age ≥ 2wks and ≤3mths
* surpassed birth weight

Exclusion Criteria:

Mother

* cardiac anomalies
* breast or endocrine abnormalities (i.e. breast CA, pituitary adenomas)
* medications contraindicated with domperidone use
* drug or alcohol use
* use of hormonal contraception

Infant

* physical anomalies making breastfeeding difficult (i.e. cleft palate)
* cardiac anomalies
D: Inclusion Criteria:

* All pregnant women with pregestational or gestational diabetes under diet or insulin control

Exclusion Criteria:

* Patient who have epilepsy or on anti-seizure medications,
* Patients who have a history of significant depression or are on antidepressant drugs
* Patients who have pheochromocytoma or uncontrolled hypertension
* Patients who have intestinal bleeding or obstruction
* Patient with known allergy or prior reaction to metoclopramide
* Patient with HIV infection
* Current pregnancy complicated by fetal congenital anomalies and multiple fetuses

Answer: A