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

NCT05514847 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: HSR220148
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Pregnancy Related

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  from before 14 weeks gestation age through delivery (up to 41 weeks gestation)

Secondary Outcomes (3)

• 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

  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

  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

  from before 14 weeks gestation age through discharge from hospital following delivery (up to 6 weeks post birth)

Study Arms (4)

1 Control Group

NO INTERVENTION

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.

2 Randomized Group 1

ACTIVE COMPARATOR

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

3 Standard of Care Group

OTHER

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 Randomized Group 2

ACTIVE COMPARATOR

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

Interventions

Aspirin 81Mg Ec Tab DRUG

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

2 Randomized Group 1; 3 Standard of Care Group; Group 4 Randomized Group 2

Aspirin 162Mg Ec Tab DRUG

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

2 Randomized Group 1; Group 4 Randomized Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Must be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Priyanka Kumar

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be randomized into 1 of 4 groups based on their results of two screening tests for preeclampsia.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 24, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)