Please select the eligibility criteria that correspond to the clinical trial below.
Title: Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
Brief Summary: This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of routine provider, primary care-based interventions to increase breastfeeding intensity up to 6 months in low-income multiethnic women, with stratification for maternal country of birth. The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions will be tested, compared to a Control standard of care. The intervention and design build upon our prior trial of an LC intervention alone.

PNCs- certified nurse midwives and ob/gyns-- will use a brief, electronically prompted protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will collect infant feeding, and health visit data outside the medical center. Medical center visit data will be obtained from MIS data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months
2. Exclusive Breastfeeding at 1,3, and 6 Months

   Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
3. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses
4. To describe participant and provider (LC and PNC) experience of the interventions.


Options:
A: Inclusion Criteria:

* Diagnosis of Gestational Diabetes Mellitus

Exclusion Criteria:

* Ever diagnosed with diabetes when not pregnant
* Ever diagnosed with cardiovascular disease
* Ever diagnosed with lung disease
* Hemoglobin \< 9.5 mg/dl
* Hematocrit less than 30%
* SBP \>= 140 or DBP \>= 90 in the last month
* Diagnosis of thyroid disease in the last month
B: Inclusion Criteria:

* Mothers booked for delivery in Dunedin, New Zealand

Exclusion Criteria:

* Women booked after 34 weeks gestation,
* Identified congenital abnormality likely to affect feeding and/or growth
* Home address outside of metropolitan Dunedin or Invercargill,
* Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
* Unable to communicate in English or te reo Maori.
C: Inclusion Criteria:

* 12-30 weeks pregnant
* receives prenatal care at Centennial women's center of Montefiore Medical Center
* English or Spanish speaking

Exclusion Criteria:

* pregnant with multiples
* breastfeeding contra-indicated
D: Inclusion Criteria:

* Enrolled/plan to remain in care at the site throughout their pregnancy
* 1st or 2nd trimester (randomization will include trimester as a blocking factor)
* Aged 18 or older
* Can provide a reliable phone number and at least 2 alternative contacts
* Are carrying a singleton pregnancy
* Can communicate in English or Spanish

Exclusion Criteria:

* High risk of prematurity/NICU (e.g., ESRD, multiple prior preterms, congenital anomalies)
* Medical/obstetrical complications for which BF is or may be perceived to be contra-indicated (e.g., HIV+, HTLV-1, breast reduction surgery, Hepatitis B and C, pre-gestational diabetes )
* On chronic medications incompatible with BF (e.g., hypoglycemics, lithium, ciprofloxacin)
* Enrolled in site's Group Pre-natal Care (app. 60 women/year)
* Previously enrolled in MILK study
* Craniofacial or neurological conditions that prevent an infant from BF (post-partum exclusion)
* Reported use of street drugs (responds to reviewer comment of how to control for this)

Answer: D