Understanding the Influence of Pregnancy on Breast Milk
Condition: Pregnancy; Breastfeeding
Study type: Observational

Summary: 
      The purpose of this study is to identify the influences of pregnancy on breast milk and the
      effects of these on the health of babies during the first 2 months of life. The investigators
      hypothesize that overweight and obese mothers will have lower serum n-3 to n-6 PUFA ratios
      during pregnancy and postpartum than normal weight mothers and will be positively correlated
      with TNF-α, IL-1β, resistin, and negatively correlated ghrelin levels both in serum and in
      breast milk in postpartum.
    

Detailed description: 
      The Mom2Baby Pilot study will last about 4 months. Up to 20 pregnant women who were
      considered normal weight prior to pregnancy will be enrolled in the study. The infants born
      to these pregnant women will also be enrolled after birth. Archive blood, archive breast
      milk, and clinical assessment data from up to 20 participants who were considered overweight
      or obese at enrollment in the Expecting Success study conducted at Pennington Biomedical
      Research Center (NCT01610752) may be used to test the primary hypothesis as well as
      additional hypotheses.

      We will measure levels of LC-PUFAS, pro-inflammatory biomarkers, and regulatory hormones
      (resistin, ghrelin) in serum (35,0-36,6 weeks gestation and 4,0-7,6 weeks postpartum) and
      breast milk (4,0-7,6 weeks postpartum) in normal weight (n=20) and overweight and obese
      (n=20) mothers. Blood serum and plasma and breast milk levels of these measures will be
      compared from pregnancy to postpartum within and between normal weight and overweight and
      obese women. Additional maternal procedures including questionnaires, anthropometrics, body
      composition measurements, energy intake measurement, and physical activity measurement will
      be investigated at 35,0-36,6 weeks gestation and 4,0-7,6 weeks postpartum. Infant procedures
      including anthropometrics, body composition measurements, stool collection, and energy intake
      measurement will be investigated at 0,1-0,6 weeks and 4,0-7,6 weeks postpartum.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Up to 20 pregnant women who were considered normal weight (18.5 ≤ BMI ≤ 24.9 kg/m2) prior
        to pregnancy will be enrolled in the study.

        Archive blood, archive breast milk, and clinical assessment data from 15 participants who
        were considered overweight and obese at enrollment in the Expecting Success study conducted
        at Pennington Biomedical Research Center (NCT01610752) will be used to represent the
        overweight and obese sample.
      
Biospecimen description: 
      Maternal Blood Collection: approximately 60 mL of blood will be collected over 2 timepoints

      Breast Milk Collection: approximately 50-100 mL of breast milk will be collected at 1
      timepoint

      Infant Stool Collection: 1 fresh infant stool sample will be collected at 1 timepoint