The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
NCT Number: NCT03961360
To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.
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Notify Me18 year–45 year
Female
Interventional
Phase 2 / Phase 3
Houston, Texas, 77030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR 2. At least stage I hypertension during pregnancy
OR
Exclusion criteria
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Time frame: 3-7 months
based on American College Obstetrics and Gynecology (ACOG) guidelines
Time frame: less than 37 weeks gestational age (GA)
Time frame: 3-7 months
development of hypertension anytime during pregnancy based on ACOG guidelines
Time frame: 1 day
Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN
Time frame: 20 weeks
onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines
Time frame: 4 weeks
group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples
Time frame: 1-24 hrs post delivery
excessive bleeding following the birth of a baby
Time frame: during labor to 24 hrs post delivery
any other bleeding associated with birth not otherwise categorized
Time frame: during delivery
peripartum
Time frame: at delivery
Time frame: at delivery
Time frame: 5 minutes post delivery
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Time frame: at delivery
Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
bleeding inside or around the ventricles in the brain.
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
chronic lung disease that affects newborns (mostly premature) and infants.
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
medical condition where a portion of the bowel dies
The University of Texas Health Science Center, Houston
Other
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)
Acronym: ASPREO
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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