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NCT Number: NCT06319014

Physical Activity to Mitigate PreEclampsia Risk

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Exercise Modes

Behavioral

Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise

Primary outcomes

  1. Systolic Blood Pressure (16wks)

    Time frame: 16 weeks gestation

    resting SBP

  2. Systolic Blood Pressure (20wks)

    Time frame: 20 weeks gestation

    resting SBP

  3. Systolic Blood Pressure (24wks)

    Time frame: 24 weeks gestation

    resting SBP

  4. Systolic Blood Pressure (28wks)

    Time frame: 28 weeks gestation

    resting SBP

  5. Systolic Blood Pressure (32wks)

    Time frame: 32 weeks gestation

    resting SBP

  6. Systolic Blood Pressure (36wks)

    Time frame: 36 weeks gestation

    resting SBP

  7. Maternal Cardiometabolic Risk (CMR) Score

    Time frame: 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

  8. Symptom Occurrence

    Time frame: at delivery

    maternal medical record and questionnaire data for occurrence, signs, and symptoms of hypertension/pre-eclampsia

  9. Placental Efficiency

    Time frame: at delivery

    placental weight gain and birth weight will be used to calculate placental efficiency

  10. Birth Weight

    Time frame: at delivery

    infant birth weight

  11. Infant Cardiometabolic Risk (CMR) Score

    Time frame: 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 outcomes

  1. Maternal Heart Rate (16wks)

    Time frame: 16 weeks gestation

    resting heart rate

  2. Maternal Heart Rate (20wks)

    Time frame: 20 weeks gestation

    resting heart rate

  3. Maternal Heart Rate (24wks)

    Time frame: 24 weeks gestation

    resting heart rate

  4. Maternal Heart Rate (28wks)

    Time frame: 28 weeks gestation

    resting heart rate

  5. Maternal Heart Rate (32wks)

    Time frame: 32 weeks gestation

    resting heart rate

  6. Maternal Heart Rate (36wks)

    Time frame: 36 weeks gestation

    resting heart rate

  7. Maternal Blood Pressure (16wks)

    Time frame: 16 weeks gestation

    resting bp

  8. Maternal Blood Pressure (20wks)

    Time frame: 20 weeks gestation

    resting bp

  9. Maternal Blood Pressure (24wks)

    Time frame: 24 weeks gestation

    resting bp

  10. Maternal Blood Pressure (28wks)

    Time frame: 28 weeks gestation

    resting bp

  11. Maternal Blood Pressure (32wks)

    Time frame: 32 weeks gestation

    resting bp

  12. Maternal Blood Pressure (36wks)

    Time frame: 36 weeks gestation

    resting bp

  13. Maternal Body Fat % (16wks)

    Time frame: 16 weeks gestation

    estimated body fat %

  14. Maternal Body Fat % (20wks)

    Time frame: 20 weeks gestation

    estimated body fat %

  15. Maternal Body Fat % (24wks)

    Time frame: 24 weeks gestation

    estimated body fat %

  16. Maternal Body Fat % (28wks)

    Time frame: 28 weeks gestation

    estimated body fat %

  17. Maternal Body Fat % (32wks)

    Time frame: 32 weeks gestation

    estimated body fat %

  18. Maternal Body Fat % (36wks)

    Time frame: 36 weeks gestation

    estimated body fat %

  19. Maternal Circumferences (16wks)

    Time frame: 16 weeks gestation

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

  20. Maternal Circumferences (20wks)

    Time frame: 20 weeks gestation

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

  21. Maternal Circumferences (24wks)

    Time frame: 24 weeks gestation

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

  22. Maternal Circumferences (28wks)

    Time frame: 28 weeks gestation

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

  23. Maternal Circumferences (32wks)

    Time frame: 32 weeks gestation

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

  24. Maternal Circumferences (36wks)

    Time frame: 36 weeks gestation

    measurements will be assessed using a 3D Scanner and Gulick measuring tape

  25. Gestational Weight Gain

    Time frame: at delivery

    weight at delivery minus pre-pregnancy weight

  26. Delivery Mode

    Time frame: at delivery

    mode of delivery (i.e. vaginal, C-section, instrumentation) will be taken from EHR

  27. Maternal Blood Glucose (16wks)

    Time frame: 16 weeks gestation

    blood glucose measured from venipuncture

  28. Maternal Blood Glucose (20wks)

    Time frame: 20 weeks gestation

    blood glucose measured from venipuncture

  29. Maternal Blood Glucose (24wks)

    Time frame: 24 weeks gestation

    blood glucose measured from venipuncture

  30. Maternal Blood Glucose (28wks)

    Time frame: 28 weeks gestation

    blood glucose measured from venipuncture

  31. Maternal Blood Glucose (32wks)

    Time frame: 32 weeks gestation

    blood glucose measured from venipuncture

  32. Maternal Blood Glucose (36wks)

    Time frame: 36 weeks gestation

    blood glucose measured from venipuncture

  33. Maternal Blood Lipids (16wks)

    Time frame: 16 weeks gestation

    blood lipids measured from venipuncture

  34. Maternal Blood Lipids (20wks)

    Time frame: 20 weeks gestation

    blood lipids measured from venipuncture

  35. Maternal Blood Lipids (24wks)

    Time frame: 24 weeks gestation

    blood lipids measured from venipuncture

  36. Maternal Blood Lipids (28wks)

    Time frame: 28 weeks gestation

    blood lipids measured from venipuncture

  37. Maternal Blood Lipids (32wks)

    Time frame: 32 weeks gestation

    blood lipids measured from venipuncture

  38. Maternal Blood Lipids (36wks)

    Time frame: 36 weeks gestation

    blood lipids measured from venipuncture

  39. Maternal Plasma Inflammatory Markers (16wks)

    Time frame: 16 weeks gestation

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

  40. Maternal Plasma Inflammatory Markers (20wks)

    Time frame: 20 weeks gestation

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

  41. Maternal Plasma Inflammatory Markers (24wks)

    Time frame: 24 weeks gestation

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

  42. Maternal Plasma Inflammatory Markers (28wks)

    Time frame: 28 weeks gestation

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

  43. Maternal Plasma Inflammatory Markers (32wks)

    Time frame: 32 weeks gestation

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

  44. Maternal Plasma Inflammatory Markers (36wks)

    Time frame: 36 weeks gestation

    inflammatory markers (i.e., IL-1b, IL-6, IL-8, TNF-a, CRP)

  45. -omics Metabolites (16wks)

    Time frame: 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

  46. -omics Metabolites (20wks)

    Time frame: 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

  47. -omics Metabolites (24wks)

    Time frame: 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

  48. -omics Metabolites (28wks)

    Time frame: 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

  49. -omics Metabolites (32wks)

    Time frame: 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

  50. -omics Metabolites (36wks)

    Time frame: 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

  51. Cord Blood and Placental Inflammatory Markers

    Time frame: at delivery

    inflammatory markers (i.e., IL-1b, IL-6, IL-8,TNF-a, CRP)

  52. Cord Blood and Placental -omics Metabolites

    Time frame: 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

  53. Infant Body Morphometric Measures

    Time frame: at delivery

    circumferences and weight/length

Study contacts

Contact information is provided by the study sponsor or research team.

James DeVente, MD

CONTACT

[email protected]

Linda E May, MS, PhD

CONTACT

[email protected]

2527377072

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

Physical Activity to Mitigate PreEclampsia Risk (PAMPER)

Acronym: PAMPER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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