Prescribing Exercise as Medicine in Pregnancy
Status: | Withdrawn |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 8/4/2018 |
Start Date: | July 1, 2018 |
End Date: | December 1, 2020 |
Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial
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.
evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
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.
Once screened and consented, participants will be randomized to either the intervention or
control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription
and the control group will receive routine care as usual. Physical activity will be monitored
with a Polar fitness tracking device.
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).
evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
Once screened and consented, participants will be randomized to either the intervention or
control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription
and the control group will receive routine care as usual. Physical activity will be monitored
with a Polar fitness tracking device.
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).
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
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