Pre-Eclampsia
Conditions
Brief 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.
Interventions
BEHAVIORALExercise Modes
Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Pregnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, rating of perceived exertion (RPE), 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (16wks) | 16 weeks gestation | resting SBP |
| Systolic Blood Pressure (20wks) | 20 weeks gestation | resting SBP |
| Systolic Blood Pressure (24wks) | 24 weeks gestation | resting SBP |
| Systolic Blood Pressure (28wks) | 28 weeks gestation | resting SBP |
| Systolic Blood Pressure (32wks) | 32 weeks gestation | resting SBP |
| Systolic Blood Pressure (36wks) | 36 weeks gestation | resting SBP |
| Maternal Cardiometabolic Risk (CMR) Score | during pregnancy | summation of age- and sexstandardized z-scores for waist circumference (or BMI), triglycerides, systolic blood pressure (SBP), glucose (insulin or HOMA-IR), and inverse HDL, with a lower CMR score indicating lower risk |
| Symptom Occurrence | at delivery | maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia |
| Placental Efficiency | at delivery | placental weight gain and birth weight will be used to calculate placental efficiency |
| Birth Weight | at delivery | infant birth weight |
| Infant Cardiometabolic Risk (CMR) Score | at delivery | The CMR score will be a summation of age- and sex-standardized z-scores for abdominal circumference (or BMI),systolic blood pressure (SBP), glucose, and inverse HDL, with a lower CMR score indicating lower risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Heart Rate (16wks) | 16 weeks gestation | resting heart rate |
| Maternal Heart Rate (20wks) | 20 weeks gestation | resting heart rate |
| Maternal Heart Rate (24wks) | 24 weeks gestation | resting heart rate |
| Maternal Heart Rate (28wks) | 28 weeks gestation | resting heart rate |
| Maternal Heart Rate (32wks) | 32 weeks gestation | resting heart rate |
| Maternal Heart Rate (36wks) | 36 weeks gestation | resting heart rate |
| Maternal Blood Pressure (16wks) | 16 weeks gestation | resting bp |
| Maternal Blood Pressure (20wks) | 20 weeks gestation | resting bp |
| Maternal Blood Pressure (24wks) | 24 weeks gestation | resting bp |
| Maternal Blood Pressure (28wks) | 28 weeks gestation | resting bp |
| Maternal Blood Pressure (32wks) | 32 weeks gestation | resting bp |
| Maternal Blood Pressure (36wks) | 36 weeks gestation | resting bp |
| Maternal Body Fat % (16wks) | 16 weeks gestation | estimated body fat % |
| Maternal Body Fat % (20wks) | 20 weeks gestation | estimated body fat % |
| Maternal Body Fat % (24wks) | 24 weeks gestation | estimated body fat % |
| Maternal Body Fat % (28wks) | 28 weeks gestation | estimated body fat % |
| Maternal Body Fat % (32wks) | 32 weeks gestation | estimated body fat % |
| Maternal Body Fat % (36wks) | 36 weeks gestation | estimated body fat % |
| Maternal Circumferences (16wks) | 16 weeks gestation | measurements will be assessed using a 3D Scanner and Gulick measuring tape |
| Maternal Circumferences (20wks) | 20 weeks gestation | measurements will be assessed using a 3D Scanner and Gulick measuring tape |
| Maternal Circumferences (24wks) | 24 weeks gestation | measurements will be assessed using a 3D Scanner and Gulick measuring tape |
| Maternal Circumferences (28wks) | 28 weeks gestation | measurements will be assessed using a 3D Scanner and Gulick measuring tape |
| Maternal Circumferences (32wks) | 32 weeks gestation | measurements will be assessed using a 3D Scanner and Gulick measuring tape |
| Maternal Circumferences (36wks) | 36 weeks gestation | measurements will be assessed using a 3D Scanner and Gulick measuring tape |
| Gestational Weight Gain | at delivery | weight at delivery minus pre-pregnancy weight |
| Delivery Mode | at delivery | mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR |
| Maternal Blood Glucose (16wks) | 16 weeks gestation | blood glucose measured from venipuncture |
| Maternal Blood Glucose (20wks) | 20 weeks gestation | blood glucose measured from venipuncture |
| Maternal Blood Glucose (24wks) | 24 weeks gestation | blood glucose measured from venipuncture |
| Maternal Blood Glucose (28wks) | 28 weeks gestation | blood glucose measured from venipuncture |
| Maternal Blood Glucose (32wks) | 32 weeks gestation | blood glucose measured from venipuncture |
| Maternal Blood Glucose (36wks) | 36 weeks gestation | blood glucose measured from venipuncture |
| Maternal Blood Lipids (16wks) | 16 weeks gestation | blood lipids measured from venipuncture |
| Maternal Blood Lipids (20wks) | 20 weeks gestation | blood lipids measured from venipuncture |
| Maternal Blood Lipids (24wks) | 24 weeks gestation | blood lipids measured from venipuncture |
| Maternal Blood Lipids (28wks) | 28 weeks gestation | blood lipids measured from venipuncture |
| Maternal Blood Lipids (32wks) | 32 weeks gestation | blood lipids measured from venipuncture |
| Maternal Blood Lipids (36wks) | 36 weeks gestation | blood lipids measured from venipuncture |
| Maternal Plasma Inflammatory Markers (16wks) | 16 weeks gestation | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) |
| Maternal Plasma Inflammatory Markers (20wks) | 20 weeks gestation | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) |
| Maternal Plasma Inflammatory Markers (24wks) | 24 weeks gestation | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) |
| Maternal Plasma Inflammatory Markers (28wks) | 28 weeks gestation | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) |
| Maternal Plasma Inflammatory Markers (32wks) | 32 weeks gestation | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) |
| Maternal Plasma Inflammatory Markers (36wks) | 36 weeks gestation | inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP) |
| -omics Metabolites (16wks) | 16 weeks gestation | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| -omics Metabolites (20wks) | 20 weeks gestation | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| -omics Metabolites (24wks) | 24 weeks gestation | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| -omics Metabolites (28wks) | 28 weeks gestation | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| -omics Metabolites (32wks) | 32 weeks gestation | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| -omics Metabolites (36wks) | 36 weeks gestation | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| Cord Blood and Placental Inflammatory Markers | at delivery | inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP) |
| Cord Blood and Placental -omics Metabolites | at delivery | MS core facility uses an Ultimate nano-liquid chromatography/Thermo Orbitrap Q-Exactive Plus and an Eskigent 425 micro-liquid chromatography/AB Sciex 5600+ Triple TOF (LC/MS) for our global proteomics and metabolomics analyses |
| Infant Body Morphometric Measures | at delivery | circumferences and weight/length |
Countries
United States
Contacts
CONTACTLinda E May, MS, PhD
CONTACTJames DeVente, MD
PRINCIPAL_INVESTIGATORLinda E May, MS, PhD
East Carolina University
Outcome results
None listed