Physical Activity to Mitigate PreEclampsia Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Modes.
- Who it may be relevant to
- Registry conditions: Pre-Eclampsia. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Physical Activity to Mitigate PreEclampsia Risk (PAMPER)
Overview
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.
Interventions
- Behavioral Exercise Modes
Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Primary outcome measures
- Systolic Blood Pressure (16wks) [Time frame: 16 weeks gestation]
- Systolic Blood Pressure (20wks) [Time frame: 20 weeks gestation]
- Systolic Blood Pressure (24wks) [Time frame: 24 weeks gestation]
- Systolic Blood Pressure (28wks) [Time frame: 28 weeks gestation]
- Systolic Blood Pressure (32wks) [Time frame: 32 weeks gestation]
- Systolic Blood Pressure (36wks) [Time frame: 36 weeks gestation]
- Maternal Cardiometabolic Risk (CMR) Score [Time frame: during pregnancy]
- Symptom Occurrence [Time frame: at delivery]
- Placental Efficiency [Time frame: at delivery]
- Birth Weight [Time frame: at delivery]
Secondary outcome measures (12)
- Maternal Heart Rate (16wks) [Time frame: 16 weeks gestation]
- Maternal Heart Rate (20wks) [Time frame: 20 weeks gestation]
- Maternal Heart Rate (24wks) [Time frame: 24 weeks gestation]
- Maternal Heart Rate (28wks) [Time frame: 28 weeks gestation]
- Maternal Heart Rate (32wks) [Time frame: 32 weeks gestation]
- Maternal Heart Rate (36wks) [Time frame: 36 weeks gestation]
- Maternal Blood Pressure (16wks) [Time frame: 16 weeks gestation]
- Maternal Blood Pressure (20wks) [Time frame: 20 weeks gestation]
- Maternal Blood Pressure (24wks) [Time frame: 24 weeks gestation]
- Maternal Blood Pressure (28wks) [Time frame: 28 weeks gestation]
- Maternal Blood Pressure (32wks) [Time frame: 32 weeks gestation]
- Maternal Blood Pressure (36wks) [Time frame: 36 weeks gestation]
Eligibility criteria
Inclusion criteria
- healthy women, age 18-40 years, <16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.
Exclusion criteria
- pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- East Carolina University — Greenville
Identifiers
NCT: NCT06319014 · 23-001568