Preterm Birth Clinical Trial
Official title:
Quantitative Activity Levels and Gestational Age at Delivery: A Prospective Cohort Study Among Nulliparous Women
NCT number | NCT03304782 |
Other study ID # | AAAR3883 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 24, 2017 |
Est. completion date | July 1, 2019 |
Verified date | November 2019 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 1, 2019 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Average number of steps for those women who deliver prior to 37 weeks gestation | Average number of steps for those women who deliver prior to 37 weeks gestation | Duration of pregnancy (< 9months) | |
Secondary | Average number of steps for those women who delivery prior to 34 weeks gestation | Average number of steps for those women who delivery prior to 34 weeks gestation | Duration of pregnancy (< 9months) | |
Secondary | Change in steps per week | Change in steps per week over each trimester | Duration of pregnancy (< 9months) | |
Secondary | Number of triage visits | Number of triage visits for threatened preterm labor | Duration of pregnancy (< 9months) | |
Secondary | Number of inpatient hospitalizations | Number of inpatient hospitalizations for threatened preterm labor | Duration of pregnancy (< 9months) | |
Secondary | Incidence of adverse maternal outcomes | Incidence of adverse maternal outcomes including pre-eclampsia, diabetes | Duration of pregnancy (<9months) | |
Secondary | Incidence of adverse fetal outcomes | Incidence of adverse fetal outcomes including Intrauterine growth restriction (IUGR), oligohydramnios, placental abruption | Duration of pregnancy (<9months) | |
Secondary | Incidence of cesarean section | Incidence of cesarean section | Duration of pregnancy (< 9months) | |
Secondary | Pregnancy physical activity questionnaire (PPAQ) | The PPAQ is a validated, self-administered questionnaire that takes on average 10-15 minutes to complete, and has been used to assess the current physical activity levels of pregnant women. This questionnaire is composed of 32 questions, grouped into different types of activities. an estimated average metabolic equivalent (MET-hr/wk) value will be calculated. Clinical practice guidelines have shown that achieving 8.5 MET-hr/wk is associated with healthy gestational weight gain (GWG). | Duration of pregnancy (< 9months) | |
Secondary | Perceived Stress Scale (PSS) | The PSS is a classic stress assessment instrument. For each question, the answers are ranked as follows: 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often, 4 - very often. A calculated total score can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 - low stress; 14-26 - moderate stress; 27-40 - high perceived stress. | Duration of pregnancy (< 9months) |
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