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Clinical Trials/NCT02586714
NCT02586714
Completed
Not Applicable

Maternal Body Composition Regulates Placental Function

National Center for Research Resources (NCRR)0 sites41 target enrollmentJuly 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
National Center for Research Resources (NCRR)
Enrollment
41
Primary Endpoint
Compare maternal body fat measurement
Status
Completed
Last Updated
9 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2012
End Date
December 1, 2013
Last Updated
9 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
National Center for Research Resources (NCRR)
Responsible Party
Principal Investigator
Principal Investigator

Nicole Marshall

Primary Investigator

National Center for Research Resources (NCRR)

Eligibility Criteria

Inclusion Criteria

  • Healthy pregnant women at term with singleton gestation

Exclusion Criteria

  • Medical condition requiring daily medication Fetal congenital anomalies Diabetes

Outcomes

Primary Outcomes

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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