Physical Activity to Mitigate PreEclampsia Risk

Pre-Eclampsia Clinical Trial

— PAMPER  

Official title:

Physical Activity to Mitigate PreEclampsia Risk (PAMPER)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319014
• Other study ID #: 23-001568
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2024
• Source: East Carolina University
• Contact: Linda E May, MS, PhD
• Phone: 2527377072
• Email: mayl[@]ecu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 comorbid conditions (hypertension, excessive weight gain, increased BMI). However, our 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. We hypothesize that we will find the following changes:(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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: October 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Behavioral:
• Exercise Modes
Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure (16wks)	resting SBP	16 weeks gestation
Primary	Systolic Blood Pressure (20wks)	resting SBP	20 weeks gestation
Primary	Systolic Blood Pressure (24wks)	resting SBP	24 weeks gestation
Primary	Systolic Blood Pressure (28wks)	resting SBP	28 weeks gestation
Primary	Systolic Blood Pressure (32wks)	resting SBP	32 weeks gestation
Primary	Systolic Blood Pressure (36wks)	resting SBP	36 weeks gestation
Primary	Maternal Cardiometabolic Risk (CMR) Score	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	during pregnancy
Primary	Symptom Occurrence	maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia	at delivery
Primary	Placental Efficiency	placental weight gain and birth weight will be used to calculate placental efficiency	at delivery
Primary	Birth Weight	infant birth weight	at delivery
Primary	Infant Cardiometabolic Risk (CMR) Score	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.	at delivery
Secondary	Maternal Heart Rate (16wks)	resting heart rate	16 weeks gestation
Secondary	Maternal Heart Rate (20wks)	resting heart rate	20 weeks gestation
Secondary	Maternal Heart Rate (24wks)	resting heart rate	24 weeks gestation
Secondary	Maternal Heart Rate (28wks)	resting heart rate	28 weeks gestation
Secondary	Maternal Heart Rate (32wks)	resting heart rate	32 weeks gestation
Secondary	Maternal Heart Rate (36wks)	resting heart rate	36 weeks gestation
Secondary	Maternal Blood Pressure (16wks)	resting bp	16 weeks gestation
Secondary	Maternal Blood Pressure (20wks)	resting bp	20 weeks gestation
Secondary	Maternal Blood Pressure (24wks)	resting bp	24 weeks gestation
Secondary	Maternal Blood Pressure (28wks)	resting bp	28 weeks gestation
Secondary	Maternal Blood Pressure (32wks)	resting bp	32 weeks gestation
Secondary	Maternal Blood Pressure (36wks)	resting bp	36 weeks gestation
Secondary	Maternal Body Fat % (16wks)	estimated body fat %	16 weeks gestation
Secondary	Maternal Body Fat % (20wks)	estimated body fat %	20 weeks gestation
Secondary	Maternal Body Fat % (24wks)	estimated body fat %	24 weeks gestation
Secondary	Maternal Body Fat % (28wks)	estimated body fat %	28 weeks gestation
Secondary	Maternal Body Fat % (32wks)	estimated body fat %	32 weeks gestation
Secondary	Maternal Body Fat % (36wks)	estimated body fat %	36 weeks gestation
Secondary	Maternal Circumferences (16wks)	measurements will be assessed using a 3D Scanner and Gulick measuring tape	16 weeks gestation
Secondary	Maternal Circumferences (20wks)	measurements will be assessed using a 3D Scanner and Gulick measuring tape	20 weeks gestation
Secondary	Maternal Circumferences (24wks)	measurements will be assessed using a 3D Scanner and Gulick measuring tape	24 weeks gestation
Secondary	Maternal Circumferences (28wks)	measurements will be assessed using a 3D Scanner and Gulick measuring tape	28 weeks gestation
Secondary	Maternal Circumferences (32wks)	measurements will be assessed using a 3D Scanner and Gulick measuring tape	32 weeks gestation
Secondary	Maternal Circumferences (36wks)	measurements will be assessed using a 3D Scanner and Gulick measuring tape	36 weeks gestation
Secondary	Gestational Weight Gain	weight at delivery minus pre-pregnancy weight	at delivery
Secondary	Delivery Mode	mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR	at delivery
Secondary	Maternal Blood Glucose (16wks)	blood glucose measured from venipuncture	16 weeks gestation
Secondary	Maternal Blood Glucose (20wks)	blood glucose measured from venipuncture	20 weeks gestation
Secondary	Maternal Blood Glucose (24wks)	blood glucose measured from venipuncture	24 weeks gestation
Secondary	Maternal Blood Glucose (28wks)	blood glucose measured from venipuncture	28 weeks gestation
Secondary	Maternal Blood Glucose (32wks)	blood glucose measured from venipuncture	32 weeks gestation
Secondary	Maternal Blood Glucose (36wks)	blood glucose measured from venipuncture	36 weeks gestation
Secondary	Maternal Blood Lipids (16wks)	blood lipids measured from venipuncture	16 weeks gestation
Secondary	Maternal Blood Lipids (20wks)	blood lipids measured from venipuncture	20 weeks gestation
Secondary	Maternal Blood Lipids (24wks)	blood lipids measured from venipuncture	24 weeks gestation
Secondary	Maternal Blood Lipids (28wks)	blood lipids measured from venipuncture	28 weeks gestation
Secondary	Maternal Blood Lipids (32wks)	blood lipids measured from venipuncture	32 weeks gestation
Secondary	Maternal Blood Lipids (36wks)	blood lipids measured from venipuncture	36 weeks gestation
Secondary	Maternal Plasma Inflammatory Markers (16wks)	inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)	16 weeks gestation
Secondary	Maternal Plasma Inflammatory Markers (20wks)	inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)	20 weeks gestation
Secondary	Maternal Plasma Inflammatory Markers (24wks)	inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)	24 weeks gestation
Secondary	Maternal Plasma Inflammatory Markers (28wks)	inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)	28 weeks gestation
Secondary	Maternal Plasma Inflammatory Markers (32wks)	inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)	32 weeks gestation
Secondary	Maternal Plasma Inflammatory Markers (36wks)	inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)	36 weeks gestation
Secondary	-omics Metabolites (16wks)	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	16 weeks gestation
Secondary	-omics Metabolites (20wks)	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	20 weeks gestation
Secondary	-omics Metabolites (24wks)	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	24 weeks gestation
Secondary	-omics Metabolites (28wks)	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	28 weeks gestation
Secondary	-omics Metabolites (32wks)	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	32 weeks gestation
Secondary	-omics Metabolites (36wks)	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	36 weeks gestation
Secondary	Cord Blood and Placental Inflammatory Markers	inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP)	at delivery
Secondary	Cord Blood and Placental -omics Metabolites	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	at delivery
Secondary	Infant Body Morphometric Measures	circumferences and weight/length	at delivery