NCT02968316

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 14, 2016

Last Update Submit

November 16, 2016

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (5)

  • 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)

Study Arms (1)

Pregnant women

all consecutive pregnant women presenting for prenatal care

Other: BIA measurement

Interventions

BIA measurementOTHER

observation only

Pregnant women

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • pregnant women

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal Fetal Medicine Associates

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Nathan Fox, MD

CONTACT

2127227409nfox@mfmnyc.com

andrei rebarber, MD

CONTACT

2127227409arebarber@mfmnyc.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 18, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 18, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)