CClinicalTrials.gg
Status unknownNCT02968316Updated Nov 18, 2016

Bioelectric Impedance Analysis and Pregnancy Outcomes

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

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

This is a prospective observational study correlating Body Impedance Analysis (BIA) with pregnancy outcomes.

Read the detailed description

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:

  1. Sween et al performed BIA on 370 women and found that body fat composition correlated with the development of preeclampsia.
  2. Gomes de Silva et al performed BIA in 65 women with preeclampsia and 51 controls and found that BIA results differed between the two groups.
  3. Marshall et al performed BIA on 41 pregnant women in the third trimester as part of a multimodal analysis of body composition
  4. Xu et al correlated BIA with the onset of gestational diabetes

PROTOCOL

  • Patients in this MFM practice will be approached at the time of their initial pregnancy visit and asked to participate.
  • If they agree and sign informed consent, the following will occur:

    • The participant's name will be placed on a list of participants
    • The participant will have an InBody analysis performed by one of the office nurses or medical assistants. The results will not be shared with the participant nor the treating physicians. Rather, the results will be filed until after the participant delivers.
    • Participants will have the InBody analysis performed in each trimester at the time of scheduled office visits as well as at the post-partum visit, which is routinely scheduled at approximately 6 weeks after delivery. Those results will also not be shared with the participants or physicians.
    • After the postpartum visit, the data from the InBody analysis will be entered into a de-identified database, along with the participant's baseline characteristics, pregnancy events, and delivery outcomes, all of which are already in the participant's office chart. No personal identifiers will be required for the database. The data will be used to correlate InBody results with pregnancy outcomes.
    • The only identifier will be the actual list of participants, which is required to plan for who needs InBody analysis during their prenatal visit.
02

Conditions studied

  • Pregnancy Complications
03

In context

Pregnancy Complications

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

pregnant women

Inclusion criteria

  • pregnant women

Exclusion criteria

Exclusion Criteria:

  • refusal to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pregnant women

    all consecutive pregnant women presenting for prenatal care

    Other: BIA measurement

Interventions

  • OtherBIA measurement

    observation only

06

What researchers measure

Primary outcomes

  1. Preeclampsia

    Time frame: from date of enrollment up to 6 weeks after delivery (within 1 year)

  2. gestational diabetes

    Time frame: from date of enrollment up to 6 weeks after delivery (within 1 year)

  3. cesarean delivery

    Time frame: from date of enrollment up to delivery (within 1 year)

  4. neonatal birth weight

    Time frame: from date of enrollment up to delivery (within 1 year)

  5. gestational age at delivery

    Time frame: from date of enrollment up to delivery (within 1 year)

07

Study locations

1 site
  • Maternal Fetal Medicine Associates
    New York, New York 10128, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02968316
Lead sponsor
Maternal Fetal Medicine Associates
Responsible party
Nathan Fox (Physician, Maternal Fetal Medicine Associates) — Principal investigator
First posted
Nov 18, 2016
Start date
Jan 2017
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Nov 18, 2016

Study contacts

Nathan Fox, MD
Contact
nfox@mfmnyc.com
2127227409
andrei rebarber, MD
Contact
arebarber@mfmnyc.com
2127227409

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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