Maternal Body Composition Regulates Placental Function (MBC)

October 23, 2015 updated by: Nicole Marshall, National Center for Research Resources (NCRR)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

41

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Healthy pregnant women at term with singleton gestation who were normal weight, overweight, or obese.

Description

Inclusion Criteria:

Healthy pregnant women at term with singleton gestation

Exclusion Criteria:

Medical condition requiring daily medication Fetal congenital anomalies Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese
Other: No intervention
Observation only
Normal weight
Other: No intervention
Observation only
Overweight
Other: No intervention
Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
37 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2KL2RR024141-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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