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NCT03304782 · ClinicalTrials.gov registry record
Fitbit Activity Tracker to Predict Risk of Preterm Birth
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 150
- Enrollment target
NCT03304782: Completed study, sponsored by Columbia University.
NCT03304782 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03304782 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
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.
Primary Outcome
The difference in steps per day between women that deliver preterm versus those that deliver at term will be analyzed.
Interventions
- OTHER Fitbit activity tracker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2019-07-01 |
What the finished NCT03304782 record still lists
NCT03304782 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Fitbit activity tracker is the first listed.
NCT03304782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03304782 about?
NCT03304782 is a clinical study titled "Fitbit Activity Tracker to Predict Risk of Preterm Birth". 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 populat...
What is the current status of trial NCT03304782?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2017-10-24. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT03304782?
The interventions under investigation include: Fitbit activity tracker (OTHER).
Who is sponsoring clinical trial NCT03304782?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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