Understanding the Influence of Pregnancy on Breast Milk

Completed

Conditions studied: Pregnancy, Breastfeeding

In brief

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.

Key facts

Study ID

NCT02317653

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

18

Starts

2015-02-01

Expected to finish

2015-12-01

Last updated by the study team

2020-09-23

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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