Status:
COMPLETED
Fitbit Activity Tracker to Predict Risk of Preterm Birth
Lead Sponsor:
Columbia University
Conditions:
Preterm Birth
Preterm Delivery
Eligibility:
FEMALE
18+ years
Brief 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...
Detailed Description
Preterm birth (PTB) remains one of the leading causes of neonatal morbidity and mortality, with a variety of modifiable and non-modifiable risk factors. In an attempt to prevent PTB, activity restrict...
Eligibility Criteria
Inclusion
- Documented single viable intrauterine pregnancy at the time of enrollment
- Nulliparous women
- At least 18 years of age
- Access to a smartphone or computer
Exclusion
- 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
Key Trial Info
Start Date :
October 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03304782
Start Date
October 24 2017
End Date
July 1 2019
Last Update
November 29 2019
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032