Understanding the Influence of Pregnancy on Breast Milk

NCT02317653 | Completed

• 1 other identifier: PBRC2014-049
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• serum levels of n-3 to n-6 PUFA ratios during pregnancy will be compared to inflammatory markers and regulatory markers in blood and breast milk in both groups

  1-2 months postpartum

Secondary Outcomes (1)

• energy intake and diet quality assessed compositely with the Remote Food Photography Method developed at Pennington Biomedical during pregnancy will be compared to energy intake and diet quality in postpartum in both groups.

  1-2 months postpartum

Other Outcomes (1)

• n-3 and n-6 PUFA levels and inflammatory markers in mother's blood and breast milk will be assessed to test correlations to infants' body composition

  1-2 months postpartum

Study Arms (2)

Overweight/Obese

Archive blood, archive breast milk, and clinical assessment data from 15 participants who were considered overweight or 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 for study investigations.

Normal Weight

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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
• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Henry Nuss, Ph.D.

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 16, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

US (1)