Clinical trial NCT05514847: Low Dose Aspirin for Preterm Preeclampsia Preventionmg/day Dose in High-risk Patients
Official title: Low Dose Aspirin for Preterm Preeclampsia Prevention - a Randomized Trial of 81 Vs 162 Mg/day Dose in High-risk Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Preeclampsia
Pregnancy Related
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into 1 of 4 groups based on their results of two screening tests for preeclampsia.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Ages 18-50
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Pregnant female in the first trimester.
* Ability to take oral medication and be willing to adhere to the aspirin regimen
* Patient has a prenatal ultrasound between 11+0 through 13+6 days of gestation
* Patient who has low or high risks for preeclampsia by the ACOG (American College of Obstetricians and Gynecologists) screening tool, and low or high risks for the FMF prescreening tool for preeclampsia.

Exclusion Criteria:

* ASA allergy, known hypersensitivity to NSAIDS
* Patients with nasal polyps
* Patients with aspirin-induced asthma exacerbations
* Active peptic ulcer disease
* Severe hepatic dysfunction
* History of GI bleeding
* Pregnancy with major abnormalities demonstrated on the 11-13-week scan
* Patient presents beyond 13w6d for first prenatal visit
* Age \< 18
* Non-viable pregnancy

Primary outcomes:
measure: The impact of 81mg/day vs 162 mg/day aspirin on PAPP-A
timeFrame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
measure: The impact of 81mg/day vs 162 mg/day aspirin on PGLF (Placenta growth factor)
timeFrame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
measure: The impact of 81mg/day vs 162 mg/day aspirin on S-FLT
timeFrame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
measure: The impact of 81mg/day vs 162 mg/day aspirin on AFP (alpha fetal protein)
timeFrame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
Secondary outcomes:
measure: 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
timeFrame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
measure: The impact of 81 mg/day vs 162 mg/day aspirin on maternal outcomes
timeFrame: from before 14 weeks gestation age through delivery and resolution of any pregnancy and delivery-related illnesses (up to 6 weeks postpartum)
measure: The impact of 81 mg/day vs 162 mg/day aspirin on fetal outcomes
timeFrame: from before 14 weeks gestation age through discharge from hospital following delivery (up to 6 weeks post birth)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Priyanka Kumar
role: PRINCIPAL_INVESTIGATOR
References: