Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
Brief Summary: Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.


Options:
A: 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
B: Inclusion Criteria:

* Babies with gestational age of 35-42 weeks
* Breasfed babies
* Lactating mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life

Exclusion Criteria:

* Babies with gestational age of \<35 weeks
* Not breast feeding mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life
C: 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)
D: 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

Answer: B