Physical Activity to Mitigate Preeclampsia Risk

This study is looking at how different types of exercise during pregnancy might help women at risk for preeclampsia (a serious blood pressure condition during pregnancy). Researchers want to see if moderate intensity aerobic exercise, resistance exercise, or a combination of both can reduce the severity and occurrence of preeclampsia symptoms. They are also interested in how exercise affects the health of both the mother and the baby. You might be able to join if you are a healthy woman, aged 18-40, less than 16 weeks pregnant with one baby, and meet certain BMI requirements. The study aims to see if exercise can improve blood pressure at 16, 20, and 24 weeks of pregnancy. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 224 women to compare the effects of different exercise modes.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures blood pressure at 16, 20, and 24 weeks of gestation, indicating follow-up during this period.

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NCT06319014

Physical Activity to Mitigate PreEclampsia Risk

Recruiting
NAAges 18–40InterventionalPrevention
East Carolina University
~224 participants
Updated 2024-07-01 on ClinicalTrials.gov
What's tested:Exercise Modes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systolic Blood Pressure (16wks)
Measured over 16 weeks gestation
+10 more outcomes measured
Pre-Eclampsia
1 sites across 1 states
North Carolina1
  • Linda E May, MS, PhD · PRINCIPAL_INVESTIGATOR · East Carolina University

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Eligibility criteria

Inclusion

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

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

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

  • Placental Efficiencyat delivery

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

  • Birth Weightat delivery

    infant birth weight

  • Infant Cardiometabolic Risk (CMR) Scoreat 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.