Bioelectric Impedance Analysis and Pregnancy Outcomes

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

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications
• Intervention / Treatment: Other: BIA measurement

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Maternal Fetal Medicine Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women

Description

Inclusion Criteria:

• pregnant women

Exclusion Criteria:

• refusal to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women; all consecutive pregnant women presenting for prenatal care	Other: BIA measurement; observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preeclampsia	from date of enrollment up to 6 weeks after delivery (within 1 year)
gestational diabetes	from date of enrollment up to 6 weeks after delivery (within 1 year)
cesarean delivery	from date of enrollment up to delivery (within 1 year)
neonatal birth weight	from date of enrollment up to delivery (within 1 year)
gestational age at delivery	from date of enrollment up to delivery (within 1 year)

Collaborators and Investigators

• Sponsor: Maternal Fetal Medicine Associates

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No