Pregnancy Clinical Trial
Official title:
Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial
NCT number | NCT03239054 |
Other study ID # | 28028 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | December 1, 2020 |
Verified date | July 2018 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Age 18 to 45 years of age - Singleton pregnancy - Gestational age at or less than 20 0/7 weeks at the time of enrollment - Low risk pregnancy - Willing and able to participate in a more active lifestyle/exercise program - Smart phone able to add the "Flow mobile app". Exclusion Criteria: - Twins or higher order multiple gestations - Known congenital anomaly - Underweight BMI ( BMI less than 18.50) - High risk pregnancy - ie. hypertension, pre-existing diabetes - Women with a known contraindication to exercise - Persistent 2nd or 3rd trimester vaginal bleeding - Hemodynamically significant heart disease - Restrictive lung disease - Incompetent cervix or cerclage - Placenta previa - Premature labor or rupture of membranes - Preeclampsia - Severe anemia - Poorly controlled hypertension, seizure disorder, or hyperthyroidism - Known intrauterine growth restriction - Not cleared for exercise by the "Contraindications to Exercise from PARMED-X" form - PAVS score greater than or equal to 150 minutes/week |
Country | Name | City | State |
---|---|---|---|
United States | St. Mary's Health Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PARmed-X: Change in number of steps (physical activity level) | change in number of steps (physical activity level) | 1 year | |
Secondary | PARMed-X: Gestational Weight Gain | Gestational Weight Gain | 1 year |
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