NCT06319014

Physical Activity to Mitigate PreEclampsia Risk

Physical Activity to Mitigate PreEclampsia Risk (PAMPER)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: East Carolina University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes. Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health. Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes.

Detailed description

Approximately 5% of pregnancies worldwide and in the United States were complicated by preeclampsia. Women who develop Preeclampsia in Pregnancy go on to develop Cardiovascular issues (Catov and other studies). Further, infants from preeclamptic pregnancies are at increased risk of mortality and co-morbid conditions (hypertension, excessive weight gain, increased BMI). However, preliminary data suggests that exercise will attenuate or prevent the severity and risk of preeclampsia; thus improving health for women and children. The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The investigators hypothesize that following changes will occur:(1) improvements in the measurements of maternal resting heart rate, blood pressure, cardiometabolic risk (CMR) score, placental growth factor (PlGF), preeclampsia severity, onset of preeclampsia of symptoms at each time point (once per visit); and (2) improvements in birth and infant measurements of decreased C-sections, preterm deliveries, hospital stay, birth weight, placental efficiency at birth when exposed to different modes of maternal exercise compared no exercise (usual care) with greatest differences in AERE trained group. Ultimately, our goal is to determine which exercise program is most effective at attenuating or preventing preeclampsia and thus improving health outcomes for mother and child.

Conditions

• Pre-Eclampsia

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Modes	Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise

Timeline

• Start date: 2024-06-24
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2024-03-19
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States