Please select the eligibility criteria that correspond to the clinical trial below.
Title: Metoclopramide to Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial
Brief Summary: Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries.

Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for breastfeeding. Successful early breastfeeding establishment is important for continued breastfeeding.


Options:
A: 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
B: 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
C: 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
D: Inclusion Criteria:

* First-time expectant mother, speaks English, receiving OB care at designated practice group

Exclusion Criteria:

* 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery

Answer: B