Physical Activity to Mitigate PreEclampsia Risk
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Exercise Modes.
- Кому может быть актуально
- Состояния в реестре: Pre-Eclampsia. Базовые параметры: 18 лет — 40 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Physical Activity to Mitigate PreEclampsia Risk (PAMPER)
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Exercise Modes
Moderate intensity aerobic exercise Moderate intensity resistance exercise Moderate intensity combination exercise
Первичные конечные точки
- Systolic Blood Pressure (16wks) [Срок оценки: 16 weeks gestation]
- Systolic Blood Pressure (20wks) [Срок оценки: 20 weeks gestation]
- Systolic Blood Pressure (24wks) [Срок оценки: 24 weeks gestation]
- Systolic Blood Pressure (28wks) [Срок оценки: 28 weeks gestation]
- Systolic Blood Pressure (32wks) [Срок оценки: 32 weeks gestation]
- Systolic Blood Pressure (36wks) [Срок оценки: 36 weeks gestation]
- Maternal Cardiometabolic Risk (CMR) Score [Срок оценки: during pregnancy]
- Symptom Occurrence [Срок оценки: at delivery]
- Placental Efficiency [Срок оценки: at delivery]
- Birth Weight [Срок оценки: at delivery]
Вторичные конечные точки (12)
- Maternal Heart Rate (16wks) [Срок оценки: 16 weeks gestation]
- Maternal Heart Rate (20wks) [Срок оценки: 20 weeks gestation]
- Maternal Heart Rate (24wks) [Срок оценки: 24 weeks gestation]
- Maternal Heart Rate (28wks) [Срок оценки: 28 weeks gestation]
- Maternal Heart Rate (32wks) [Срок оценки: 32 weeks gestation]
- Maternal Heart Rate (36wks) [Срок оценки: 36 weeks gestation]
- Maternal Blood Pressure (16wks) [Срок оценки: 16 weeks gestation]
- Maternal Blood Pressure (20wks) [Срок оценки: 20 weeks gestation]
- Maternal Blood Pressure (24wks) [Срок оценки: 24 weeks gestation]
- Maternal Blood Pressure (28wks) [Срок оценки: 28 weeks gestation]
- Maternal Blood Pressure (32wks) [Срок оценки: 32 weeks gestation]
- Maternal Blood Pressure (36wks) [Срок оценки: 36 weeks gestation]
Критерии участия
Критерии включения
- healthy women, age 18-40 years, <16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.
Критерии исключения
- pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- East Carolina University — Greenville
Идентификаторы
NCT: NCT06319014 · 23-001568