Fitbit Activity Tracker to Predict Risk of Preterm Birth

NCT03304782 | Completed

• 1 other identifier: AAAR3883
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 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

Preterm Birth; Preterm Delivery

Keywords

Preterm Birth; Fitbit; Preterm Delivery

Outcome Measures

Primary Outcomes (1)

• Difference in number of steps

  The difference in steps per day between women that deliver preterm versus those that deliver at term will be analyzed.

  Duration of pregnancy (< 9months)

Secondary Outcomes (10)

• Average number of steps for those women who deliver prior to 37 weeks gestation

  Duration of pregnancy (< 9months)

• Average number of steps for those women who delivery prior to 34 weeks gestation

  Duration of pregnancy (< 9months)

• Change in steps per week

  Duration of pregnancy (< 9months)

• Number of triage visits

  Duration of pregnancy (< 9months)

• Number of inpatient hospitalizations

  Duration of pregnancy (< 9months)

Study Arms (2)

Preterm birth

Data collected using Fitbit activity tracker from women with delivery prior to 37 weeks gestation

Other: Fitbit activity tracker

Full-term birth

Data collected using Fitbit activity tracker from women with delivery after 37 weeks gestation

Other: Fitbit activity tracker

Interventions

Fitbit activity tracker OTHER

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

Full-term birth; Preterm birth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are having their first baby, and have a low risk pregnancy

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)
• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Booker WA, Ekpe EE, Handal-Orefice RC, Zhang Y, Cande A, Gyamfi-Bannerman C, Nieto V. Quantitative activity levels and gestational age at delivery: a prospective cohort study among nulliparous women. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100503. doi: 10.1016/j.ajogmf.2021.100503. Epub 2021 Oct 17.

  PMID: 34666197 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Cynthia Gyamfi, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 9, 2017
• Study Start: October 24, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)