Low Dose Aspirin for Preterm Preeclampsia Preventionmg/day Dose in High-risk Patients

NCT ID: NCT05514847

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-12-31

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.

Conditions

Preeclampsia; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1 Control Group

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 Type: NO_INTERVENTION

No interventions assigned to this group

2 Randomized Group 1

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.

Group Type: ACTIVE_COMPARATOR

Aspirin 81Mg Ec Tab

Intervention Type: DRUG

81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Aspirin 162Mg Ec Tab

Intervention Type: DRUG

162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

3 Standard of Care Group

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.

Group Type: OTHER

Aspirin 81Mg Ec Tab

Intervention Type: DRUG

81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Group 4 Randomized Group 2

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.

Group Type: ACTIVE_COMPARATOR

Aspirin 81Mg Ec Tab

Intervention Type: DRUG

81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Aspirin 162Mg Ec Tab

Intervention Type: DRUG

162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Interventions

Aspirin 81Mg Ec Tab

81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Intervention Type: DRUG

Aspirin 162Mg Ec Tab

162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Christopher S. Ennen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priyanka Kumar

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

HSR220148

Identifier Type: -

Identifier Source: org_study_id