NCT02586714

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
Last Updated

July 8, 2025

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

October 22, 2015

Last Update Submit

July 2, 2025

Conditions

ObesityPregnancy

Outcome Measures

Primary Outcomes (1)

  • Compare maternal body fat measurement

    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

Study Arms (3)

Normal weight

Other: No intervention

Overweight

Other: No intervention

Obese

Other: No intervention

Interventions

No interventionOTHER

Observation only

Normal weightObeseOverweight

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Healthy pregnant women at term with singleton gestation

You may not qualify if:

  • Medical condition requiring daily medication Fetal congenital anomalies Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Marshall NE, Murphy EJ, King JC, Haas EK, Lim JY, Wiedrick J, Thornburg KL, Purnell JQ. Comparison of multiple methods to measure maternal fat mass in late gestation. Am J Clin Nutr. 2016 Apr;103(4):1055-63. doi: 10.3945/ajcn.115.113464. Epub 2016 Feb 17.

    PMID: 26888714DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 26, 2015

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

July 8, 2025

Record last verified: 2015-10