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Fitbit Activity Tracker to Predict Risk of Preterm Birth

NCT03304782 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-11-29

No results posted yet for this study

Summary

Almost half of all deliveries in the United States are of nulliparous patients. They have been identified as an at-risk population for preterm birth. Historically, the most significant risk factor for preterm birth is a prior history of preterm birth, which cannot be applied to a nulliparous population. Forecasting adverse outcomes in first time moms is difficult to predict and prevent. Historically, physicians have prescribed a restriction in activity level for those at risk for preterm delivery. The utility of this intervention has yet to be prospectively and quantitatively studied. The Fitbit activity tracker is a wearable device that has been extensively used in medical research, in an attempt to quantitatively identify how patient activity levels can improve medical outcomes. The study uses the Fitbit device in nulliparous patients, remotely track their activity levels throughout pregnancy, and assess pregnancy outcomes. Because of the significant and long-standing health disparity in the incidence of preterm delivery, the investigators will use the "Everyday Discrimination Scale", a validated battery of racism and health to see how a patient's stress related to perceived discrimination may modify the risk of preterm delivery.

Conditions

Interventions

OTHER

Fitbit activity tracker

Wearable device that records the number of steps a person takes throughout the day

Sponsors & Collaborators

Principal Investigators

  • Cynthia Gyamfi, M.D. · Columbia University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2019-07-01
Completion
2019-07-01

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304782 on ClinicalTrials.gov