Prescribing Exercise as Medicine in Pregnancy

Saint Louis University (SLU)

Status: Withdrawn

Conditions: Pregnancy

Treatments: Behavioral: Physical activity; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03239054

28028

Details and patient eligibility

About

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.

Full description

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).

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Study Group

Experimental group

Description:

Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.

Treatment:

Behavioral: Physical activity

Control Group

Other group

Description:

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.

Treatment:

Behavioral: Control group