Fitbit Activity Tracker to Predict Risk of Preterm Birth
Completed
Conditions studied: Preterm Birth, Preterm Delivery
In brief
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.
Key facts
- Study ID
- NCT03304782
- Run by
- Columbia University
- People needed
- 150
- Starts
- 2017-10-24
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2019-11-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Documented single viable intrauterine pregnancy at the time of enrollment
- Nulliparous women
- At least 18 years of age
- Access to a smartphone or computer
You may not qualify if…
- Known or suspected major congenital anomalies or aneuploidy
- Fetal demise
- Multiple gestation
- Known maternal medical complications (increasing patient risk for indicated (planned) preterm delivery:
- Pre-gestational diabetes White's Class D or worse
- Cancer (undergoing treatment)
- Current hyperthyroidism if not adequately controlled
- Renal disease with altered renal function (serum creatinine > 1.5)
- Systemic lupus, scleroderma, polymyalgia rheumatica
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
- Platelet or red blood cell disorder
- Chronic pulmonary disease (aside from asthma)
- Structural, functional or ischemic heart disease. Neither mitral valve prolapse nor paroxysmal supraventricular tachycardia are considered exclusions.
- Known HIV positive with viral load greater than 1,000 copies/ml or cluster of differentiation 4 (CD4) count less than 350/mm3
- Current or planned cerclage
- Planned delivery prior to 37 weeks
- Planned delivery at a non-participating hospital
- Patients who do not have regular access to a smart phone or computer
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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