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Pre-EclampsiaPAMPERNCT06319014

Physical Activity to Mitigate PreEclampsia Risk

A study testing Exercise Modes in people with Pre-Eclampsia, run by East Carolina University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pre-Eclampsia
What is being tested?
Exercise Modes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteUnited States
Study dates
24 Jun 2024to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy women, age 18-40 years, <16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.

Who cannot join

  • pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linda E May, MS, PhD contact

2527377072

mayl@ecu.edu

James DeVente, MD contact

deventeja@ecu.edu

United States1 site, 1 recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Linda E May, MS, PhD, 2527377072, mayl@ecu.edu

    James DeVente, MD, deventeja@ecu.edu

    Recruiting

Other trials in United States

About this study

Official title: Physical Activity to Mitigate PreEclampsia Risk (PAMPER)

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.

Read the 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
Being tested
Exercise Modes
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise ModesBehavioural

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

Study groups in NCT06319014
Study groupRoleWhat they receive
AE GroupExperimentalThe AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Receives: Behavioral: Exercise Modes
RE GroupExperimentalThe RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets, with a rest period of 30-60 seconds between sets as needed.[172] Seated isokinetic exercise using resistance machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on machines. Core exercises will be performed at the end of the session (i.e. seated side bends) 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Receives: Behavioral: Exercise Modes
AERE GroupExperimentalAERE group will alternate between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeat this cycle with different exercises. 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, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Receives: Behavioral: Exercise Modes
ControlNo interventionThe Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic Blood Pressure (16wks)

    resting SBP

    Measured: 16 weeks gestation

  2. Systolic Blood Pressure (20wks)

    resting SBP

    Measured: 20 weeks gestation

  3. Systolic Blood Pressure (24wks)

    resting SBP

    Measured: 24 weeks gestation

  4. Systolic Blood Pressure (28wks)

    resting SBP

    Measured: 28 weeks gestation

  5. Systolic Blood Pressure (32wks)

    resting SBP

    Measured: 32 weeks gestation

  6. Systolic Blood Pressure (36wks)

    resting SBP

    Measured: 36 weeks gestation

  7. 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

    Measured: during pregnancy

  8. Symptom Occurrence

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

    Measured: at delivery

  9. Placental Efficiency

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

    Measured: at delivery

  10. Birth Weight

    infant birth weight

    Measured: at delivery

  11. 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.

    Measured: at delivery

Secondary outcomes (53)

  1. Maternal Heart Rate (16wks)

    resting heart rate

    Measured: 16 weeks gestation

  2. Maternal Heart Rate (20wks)

    resting heart rate

    Measured: 20 weeks gestation

  3. Maternal Heart Rate (24wks)

    resting heart rate

    Measured: 24 weeks gestation

  4. Maternal Heart Rate (28wks)

    resting heart rate

    Measured: 28 weeks gestation

  5. Maternal Heart Rate (32wks)

    resting heart rate

    Measured: 32 weeks gestation

  6. Maternal Heart Rate (36wks)

    resting heart rate

    Measured: 36 weeks gestation

  7. Maternal Blood Pressure (16wks)

    resting bp

    Measured: 16 weeks gestation

  8. Maternal Blood Pressure (20wks)

    resting bp

    Measured: 20 weeks gestation

  9. Maternal Blood Pressure (24wks)

    resting bp

    Measured: 24 weeks gestation

  10. Maternal Blood Pressure (28wks)

    resting bp

    Measured: 28 weeks gestation

  11. Maternal Blood Pressure (32wks)

    resting bp

    Measured: 32 weeks gestation

  12. Maternal Blood Pressure (36wks)

    resting bp

    Measured: 36 weeks gestation

  13. Maternal Body Fat % (16wks)

    estimated body fat %

    Measured: 16 weeks gestation

  14. Maternal Body Fat % (20wks)

    estimated body fat %

    Measured: 20 weeks gestation

  15. Maternal Body Fat % (24wks)

    estimated body fat %

    Measured: 24 weeks gestation

  16. Maternal Body Fat % (28wks)

    estimated body fat %

    Measured: 28 weeks gestation

  17. Maternal Body Fat % (32wks)

    estimated body fat %

    Measured: 32 weeks gestation

  18. Maternal Body Fat % (36wks)

    estimated body fat %

    Measured: 36 weeks gestation

  19. Maternal Circumferences (16wks)

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

    Measured: 16 weeks gestation

  20. Maternal Circumferences (20wks)

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

    Measured: 20 weeks gestation

  21. Maternal Circumferences (24wks)

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

    Measured: 24 weeks gestation

  22. Maternal Circumferences (28wks)

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

    Measured: 28 weeks gestation

  23. Maternal Circumferences (32wks)

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

    Measured: 32 weeks gestation

  24. Maternal Circumferences (36wks)

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

    Measured: 36 weeks gestation

  25. Gestational Weight Gain

    weight at delivery minus pre-pregnancy weight

    Measured: at delivery

  26. Delivery Mode

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

    Measured: at delivery

  27. Maternal Blood Glucose (16wks)

    blood glucose measured from venipuncture

    Measured: 16 weeks gestation

  28. Maternal Blood Glucose (20wks)

    blood glucose measured from venipuncture

    Measured: 20 weeks gestation

  29. Maternal Blood Glucose (24wks)

    blood glucose measured from venipuncture

    Measured: 24 weeks gestation

  30. Maternal Blood Glucose (28wks)

    blood glucose measured from venipuncture

    Measured: 28 weeks gestation

  31. Maternal Blood Glucose (32wks)

    blood glucose measured from venipuncture

    Measured: 32 weeks gestation

  32. Maternal Blood Glucose (36wks)

    blood glucose measured from venipuncture

    Measured: 36 weeks gestation

  33. Maternal Blood Lipids (16wks)

    blood lipids measured from venipuncture

    Measured: 16 weeks gestation

  34. Maternal Blood Lipids (20wks)

    blood lipids measured from venipuncture

    Measured: 20 weeks gestation

  35. Maternal Blood Lipids (24wks)

    blood lipids measured from venipuncture

    Measured: 24 weeks gestation

  36. Maternal Blood Lipids (28wks)

    blood lipids measured from venipuncture

    Measured: 28 weeks gestation

  37. Maternal Blood Lipids (32wks)

    blood lipids measured from venipuncture

    Measured: 32 weeks gestation

  38. Maternal Blood Lipids (36wks)

    blood lipids measured from venipuncture

    Measured: 36 weeks gestation

  39. Maternal Plasma Inflammatory Markers (16wks)

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

    Measured: 16 weeks gestation

  40. Maternal Plasma Inflammatory Markers (20wks)

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

    Measured: 20 weeks gestation

  41. Maternal Plasma Inflammatory Markers (24wks)

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

    Measured: 24 weeks gestation

  42. Maternal Plasma Inflammatory Markers (28wks)

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

    Measured: 28 weeks gestation

  43. Maternal Plasma Inflammatory Markers (32wks)

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

    Measured: 32 weeks gestation

  44. Maternal Plasma Inflammatory Markers (36wks)

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

    Measured: 36 weeks gestation

  45. -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

    Measured: 16 weeks gestation

  46. -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

    Measured: 20 weeks gestation

  47. -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

    Measured: 24 weeks gestation

  48. -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

    Measured: 28 weeks gestation

  49. -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

    Measured: 32 weeks gestation

  50. -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

    Measured: 36 weeks gestation

  51. Cord Blood and Placental Inflammatory Markers

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

    Measured: at delivery

  52. 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

    Measured: at delivery

  53. Infant Body Morphometric Measures

    circumferences and weight/length

    Measured: at delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start24 Jun 2024
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06319014
Sponsor's protocol ID
23-001568
Acronym
PAMPER
Status last verified
Sep 2026
First submitted
12 Mar 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: de-identified data can be shared upon request to researchers

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Modes in people with Pre-Eclampsia, run by East Carolina University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda E May, MS, PhD (2527377072, mayl@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (16wks) (time frame: 16 weeks gestation). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06319014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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