PregnancyMom2Baby PilotNCT02317653
Understanding the Influence of Pregnancy on Breast Milk
An observational study of Pregnancy and Breastfeeding, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Breastfeeding
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Conditions
- Pregnancy, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1-2 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Henry J. Nuss, Ph.D., Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Henry Nuss, Ph.D., Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317653
- Sponsor's protocol ID
- PBRC2014-049
- Acronym
- Mom2Baby Pilot
- Status last verified
- Sep 2020
- First submitted
- 8 Dec 2014
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mom2Baby Pilot: Understanding the Influence of Pregnancy on Breast Milk
- ClinicalTrials.gov ID
- NCT02317653
- Acronym / sponsor ID
- Mom2Baby Pilot / PBRC2014-049
- Conditions
- Pregnancy, Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Nuss, Ph.D. principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Breastfeeding, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.