Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-07-01
2020-12-01
Brief Summary
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Detailed Description
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Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or absence of gestational diabetes and presence or absence of hypertensive disorders of pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores, arterial cord blood gases.
Psychological outcomes will also be assessed using several validated scales in pregnancy including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety Inventory (STAI).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Study Group
Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.
Physical activity
pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
Control Group
The control group will be provided with the ACOG Pamphlet entitled "Exercise during pregnancy" and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled.
Control group
Information will be given as part of standard care
Interventions
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Physical activity
pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
Control group
Information will be given as part of standard care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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St. Louis University
OTHER
Responsible Party
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Shilpa Babbar, MD
Principal Investigator
Principal Investigators
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Shilpa Babbar, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Locations
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St. Mary's Health Center
St Louis, Missouri, United States
Countries
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Other Identifiers
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28028
Identifier Type: -
Identifier Source: org_study_id
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