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Maternal Body Composition Regulates Placental Function (MBC)

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ClinicalTrials.gov Identifier: NCT02586714
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Nicole Marshall, National Center for Research Resources (NCRR)

Brief Summary:
This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy.

Condition or disease Intervention/treatment
Obesity Pregnancy Other: No intervention

Detailed Description:

This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. This project integrates body composition analysis, nutrition, and metabolic factors to study the impact of maternal body composition and diet on placental function and fetal growth.

Research Project: The proposed enrollment of 41 pregnant women at term (>37 weeks gestation) was completed in September 2013. The subjects underwent four body composition measurements (bioelectrical impedance, skin-fold thickness, BodPod, and deuterium dilution) and dietary surveys along with a fasting blood draw. The subjects returned 2 weeks postpartum for repeat measurements along with a DEXA scan.


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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Body Composition Regulates Placental Function
Study Start Date : July 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
Normal weight Other: No intervention
Observation only

Overweight Other: No intervention
Observation only

Obese Other: No intervention
Observation only




Primary Outcome Measures :
  1. Compare maternal body fat measurement [ Time Frame: 37 weeks gestation ]
    Subjects presented for their study visits in the morning following an overnight fast. During the first visit, at 37-38 weeks' gestation, they underwent four measures: 1) ADP, 2) TBW volume by deuterium (2H2O) dilution, 3) skin-fold thickness (SFT), and 4) bioelectrical impedance analysis (BIA). To determine maternal FM (kg) without the presence of the fetus or placenta, and to avoid radiation exposure to the fetus, subjects returned for a second study visit two weeks postpartum for repeat measurements by the above methods plus a dual-energy x-ray absorptiometry scan (DXA) scan. Statistical analysis was performed using the R package Method Comparison Regression, version 1.2.1. Estimates of mean FM (kg) were compared by analysis of variance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy pregnant women at term with singleton gestation who were normal weight, overweight, or obese.
Criteria

Inclusion Criteria:

Healthy pregnant women at term with singleton gestation

Exclusion Criteria:

Medical condition requiring daily medication Fetal congenital anomalies Diabetes


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicole Marshall, Primary Investigator, National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT02586714     History of Changes
Other Study ID Numbers: 2KL2RR024141-06 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015