A Phase 4 interventional study of Aspirin 81Mg Ec Tab and Aspirin 162Mg Ec Tab in Preeclampsia and Pregnancy Related, sponsored by University of Virginia. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by University of Virginia · Phase 4, Interventional, and Prevention
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily ASA use. Currently, all patients that present to UVA Obstetric clinics are evaluated for development of preeclampsia per the current ACOG guidelines. If they screen positive per ACOG guidelines, then it is recommended they initiate 81mg/day ASA starting at 12 weeks of pregnancy and continuing until delivery. For this study, patients that present for early first trimester ultrasound (US) (for dating and/or genetic testing + ultrasound) will be offered enrollment in the study, and consenting patients will undergo double screening tests with ACOG and the FMF-based preeclampsia screen. This test will include first trimester uterine artery PI, assessment of maternal blood pressure, a maternal history and maternal serum markers including PAPP-A, PLGF, S-FLT, AFP. The first trimester preeclampsia screen will be performed between 10 weeks, 0 days and 13 weeks, 6 days of pregnancy.
For the patients within the intervention group, repeat uterine artery PI measurements will be performed during the patient's 20-week anatomic survey ultrasound. Repeat maternal serum biomarkers will be collected with routine 28-week labs and at time of delivery (standard times for blood draws in pregnancy) for all enrolled patients. Patients will be followed longitudinally through their pregnancy and delivery and neonatal outcomes will be recorded. Delivery and timing of delivery will be based solely on obstetric indications regardless of status in the trial. All uterine artery Doppler measurements will be obtained by P.J. Kumar.
903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's planned enrollment of 150 is above the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
Control Group (Group 1): These patients will be screened negative for both the ACOG screening test and the FMF preeclampsia screen. These women will receive no aspirin.
Group 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.
Drug: Aspirin 81Mg Ec Tab · Drug: Aspirin 162Mg Ec Tab
Group 3: These patients will be screened positive for the ACOG screening test but negative for the FMF preeclampsia screen. These women will be offered 81 mg aspirin, which is the standard of care.
Drug: Aspirin 81Mg Ec Tab
Group 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.
Drug: Aspirin 81Mg Ec Tab · Drug: Aspirin 162Mg Ec Tab
81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy
162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy
The impact of 81mg/day vs 162 mg/day aspirin on PAPP-A
To assess the effect of 81mg/day vs 162mg/day on the progression of PAPP-A in pregnancy. Unit of measure is multiples of the median (MoM).
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81mg/day vs 162 mg/day aspirin on PGLF (Placenta growth factor)
To assess the effect of 81mg/day vs 162mg/day on the progression of PGLF in pregnancy. Unit of measure is multiples of the median (MoM).
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81mg/day vs 162 mg/day aspirin on S-FLT
To assess the effect of 81mg/day vs 162mg/day on the progression of S-FLT in pregnancy. Unit of measure is multiples of the median (MoM).
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81mg/day vs 162 mg/day aspirin on AFP (alpha fetal protein)
To assess the effect of 81mg/day vs 162mg/day on the progression of AFP in pregnancy. Unit of measure is multiples of the median (MoM).
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81 mg/day vs 162 mg/day aspirin dosage on Uterine artery pulsatility average in patients with 81 vs 162 mg/day of ASA
The uterine artery pulsaltility index will be reviewed. This will be obtained via doppler ultrasound studies This will be described on a continuous scale with repeated measures and analyzed using T-test and ANOVA. Uterine artery doppler pulsatile index (PI) will be measured in the first, second and third trimester of pregnancy using doppler mode on the ultrasound We will use these data to determine the ability to predict adverse outcomes by uterine artery Doppler parameters and mean arterial pressure. We predict that the uterine artery PI will be lower in the 162mg/day group compared to the 81mg/day group. Furthermore, uterine artery PI will increase in those that are at high risk of developing PE compared to the control group.
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81 mg/day vs 162 mg/day aspirin on maternal outcomes
Maternal outcomes including: * Mode of delivery * Antepartum stillbirth * Pre-pregnancy medical conditions * hemorrhage * Abruption * Development of fetal growth restriction (FGR) * Develop of hypertensive disorder of pregnancy * Post-partum blood pressure and medication adjustments * oligohydramnios, polyhydramnios, * gestational age at delivery * blood pressure at delivery * labor course including need for magnesium
Time frame: from before 14 weeks gestation age through delivery and resolution of any pregnancy and delivery-related illnesses (up to 6 weeks postpartum)
The impact of 81 mg/day vs 162 mg/day aspirin on fetal outcomes
Fetal outcomes including: * Gestational age (GA) at time of delivery * Neonatal intensive care unit (NICU) length of stay * Estimated fetal weight compared to birth weight * Intrapartum stillbirth * Need for fetal interventions including: mechanical ventilation, CPAP * Apgar scores at 1,5 minutes * Arterial cord pH * Intraventricular hemorrhage (IVH), Necrotizing enterocolitis (NEC), sepsis, neonatal death, neonatal seizures, neonatal end organ dysfunction, fetal anemia
Time frame: from before 14 weeks gestation age through discharge from hospital following delivery (up to 6 weeks post birth)
Plan to share: No
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Ran from Oct 2022 to primary completion in Dec 2023, 14 months.
Of 37 phase 4 interventional studies under Pre-Eclampsia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 35. This study's 14 months is below that.
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This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin