Pregnancy Clinical Trial
Official title:
Mom2Baby Pilot: Understanding the Influence of Pregnancy on Breast Milk
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.
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.
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