Understanding the Influence of Pregnancy on Breast Milk
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 2/17/2018 |
| Start Date: | February 2015 |
| End Date: | December 2015 |
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.
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.
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.
Inclusion Criteria:
- Female
- Pregnant (prior to 36 weeks gestation) with singleton viable pregnancy
- Not diagnosed with gestational diabetes in the 2nd trimester of current pregnancy as
determined by 2nd trimester oral glucose tolerance test
- 18‐40 years of age
- Normal weight (18.5 ≤ BMI ≤ 24.9 kg/ m2) prior to pregnancy
- English speaking
- Willing to complete up to 3 clinic visits at Pennington Biomedical Research Center
- Willing to enroll infant in the study after infant is delivered
- Intend to breastfeed or provide breast milk to infant until the infant is at least 2
months of age
- Willing for study staff to contact the primary care doctor who is providing prenatal
care for the current pregnancy and to obtain information from the prenatal medical
records, the labor and delivery records and the medical records of the infant at birth
Exclusion Criteria:
- Recent history of or currently smoking
- Recent history of or current alcohol or drug abuse
- Not willing to complete up to 3 clinic visits at Pennington Biomedical Research Center
- Not willing to enroll infant in the study after infant is delivered
- Not planning on breastfeeding or providing breast milk to infant prior to 2 months of
age
- Plans to move out of the study area within the study period
- Not willing to avoid pregnancy for 2 months following delivery
- Prior or planned (within 1 year of expected delivery) bariatric surgery
- Enrollment in this study in a previous pregnancy
- Known fetal anomaly in current pregnancy
- History of preterm birth
- Planned termination or adoption of infant from current pregnancy
- History of 3 or more consecutive first trimester miscarriages
- Hypertensive (SBP>160 mmHg & DBP >110 mmHg)
- Diabetic diagnosis prior to pregnancy
- History or current psychotic disorder, major depressive episode, bipolar disorder, or
eating disorder
- Diagnosis of HIV or AIDS
- Diagnosis of severe anemia (Hb<8g/dL and/or Hct <24%)
- Current use of one or more of the following medications: Metformin, Systemic steroids,
Antipsychotic agents (e.g., Abilify, Haldol, Risperdal, Seroquel, Zyprexa),
Anti‐seizure medications or mood stabilizers that would be expected to have a
significant impact on body weight (e.g., Depakote, Lamictal, Lithium, Neurontin,
Tegretol, Topamax, Keppra), Medications for ADHD including amphetamines and
methylphenidate.
- Continued use of weight loss medication including OTC and dietary supplements for
weight loss (e.g.,Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid,
Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti‐slim, Chromium,
chitosan, Bitter orange)
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