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Trial record 1 of 1 for:    mom2baby pilot
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Understanding the Influence of Pregnancy on Breast Milk (Mom2Baby Pilot)

This study has been completed.
Sponsor:
Collaborator:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Henry J. Nuss, Ph.D., Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT02317653
First received: December 8, 2014
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition
Pregnancy Breastfeeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mom2Baby Pilot: Understanding the Influence of Pregnancy on Breast Milk

Further study details as provided by Henry J. Nuss, Ph.D., Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • 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 [ Time Frame: 1-2 months postpartum ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1-2 months postpartum ]

Other Outcome Measures:
  • 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 [ Time Frame: 1-2 months postpartum ]

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


Enrollment: 18
Study Start Date: February 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02317653

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Pennington Biomedical Research Center
Investigators
Principal Investigator: Henry Nuss, Ph.D. Louisiana State University Health Sciences Center in New Orleans
  More Information

Responsible Party: Henry J. Nuss, Ph.D., Assistant Professor, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02317653     History of Changes
Other Study ID Numbers: PBRC2014-049
Study First Received: December 8, 2014
Last Updated: April 19, 2017

ClinicalTrials.gov processed this record on September 21, 2017