The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia

NCT ID: NCT03735433

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2024-03-01

Brief Summary

Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.

Detailed Description

Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.

Conditions

Preeclampsia

Study Design

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

Study Groups

81 mg daily aspirin dose

obese women \>30 BMI at risk for preeclampsia will receive recommended 81mg ASA

Group Type: NO_INTERVENTION

No interventions assigned to this group

162mg daily aspirin dose

obese women \>30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA

Group Type: ACTIVE_COMPARATOR

162mg aspirin dose

Intervention Type: DRUG

2 pills of 81mg aspirin

Interventions

162mg aspirin dose

2 pills of 81mg aspirin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• BMI at enrollment >/= 30
• plan for ASA for preeclampsia prevention

Exclusion Criteria

• BMI < 30
• already on ASA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kara M Rood, MD

Prinicple Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State Medical Center Labor and Delivery Unit

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OBASA

Identifier Type: -

Identifier Source: org_study_id