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NCT03304782
Fitbit Activity Tracker to Predict Risk of Preterm Birth
trial testing Fitbit activity tracker in Preterm Birth in 150 participants. Completed in 1 July 2019.
1 July 2019
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 24 October 2017 |
| Primary completion | 1 July 2019 |
| Estimated completion | 1 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fitbit activity tracker
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
- Preterm Delivery — all drugs for Preterm Delivery →
Sponsor
Columbia University
Who can join
18 and older, female only, with Preterm Birth or Preterm Delivery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03304782
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03304782 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Columbia University
- Last refreshed: 29 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03304782.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing