Maternal Body Composition Regulates Placental Function

Completed

• Conditions: Pregnancy; Obesity
• Interventions: Other: No intervention

• Registration Number: NCT02586714
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Last Update Submitted: 2015-10-23
• Study First Posted: 2015-10-26
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

Healthy pregnant women at term with singleton gestation

Exclusion Criteria

Medical condition requiring daily medication Fetal congenital anomalies Diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal weight	No intervention	-
Obese	No intervention	-
Overweight	No intervention	-

Primary Outcome Measures

Name	Time	Method
Compare maternal body fat measurement	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.