An observational study in Pregnancy Complications, sponsored by Maternal Fetal Medicine Associates. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Maternal Fetal Medicine Associates · Observational
This is a prospective observational study correlating Body Impedance Analysis (BIA) with pregnancy outcomes.
BIA is a new method of measuring total body water, fat, and lean mass. It is measured noninvasively, and the investigators plan on using the InBody analyzer (www.InBody.com) in this study. The analysis takes a few seconds and only requires the participant to stand on a small platform and grasp a small device in each hand. The machine then uses low electrical current to analyze the body composition and produce a read-out.
The investigators plan on doing this analysis longitudinally across gestation in multiple trimesters to analyze the ability to predict maternal morbid conditions prior to the current clinically-based criteria as a novel marker to aid in routine prenatal care, as compared to the traditional weight measurement currently being done.
Both increased maternal prepregnancy weight (body mass index) and increased maternal gestational weight gain have been associated with increased risks of multiple obstetrical complications (both maternal and fetal). The investigators seek to compare the current standard with BIA in its ability to predict maternal/fetal adverse outcomes such as gestational diabetes, preeclampsia, and cesarean delivery.
PRIOR RESEARCH
There are a few studies in pregnant patients correlating BIA and pregnancy outcomes:
PROTOCOL
If they agree and sign informed consent, the following will occur:
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 320 across 205 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →This is the only study on the registry with Maternal Fetal Medicine Associates as lead sponsor.
Counted across the registry records on this site, refreshed daily.
pregnant women
Exclusion Criteria:
all consecutive pregnant women presenting for prenatal care
Other: BIA measurement
observation only
Preeclampsia
Time frame: from date of enrollment up to 6 weeks after delivery (within 1 year)
gestational diabetes
Time frame: from date of enrollment up to 6 weeks after delivery (within 1 year)
cesarean delivery
Time frame: from date of enrollment up to delivery (within 1 year)
neonatal birth weight
Time frame: from date of enrollment up to delivery (within 1 year)
gestational age at delivery
Time frame: from date of enrollment up to delivery (within 1 year)
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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