Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319014
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-03-12
Brief Title:
Physical Activity to Mitigate PreEclampsia Risk
Sponsor:
East Carolina University
Organization:
East Carolina University
Study Overview
Official Title:
Physical Activity to Mitigate PreEclampsia Risk PAMPER
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMPER
Brief 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 fetalneonatal 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
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
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 fetalneonatal physiological variables in women at-risk for preeclampsia The investigators hypothesize that following changes will occur1 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None