Back to results

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

Primary Purpose

Preeclampsia

Status

Suspended

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

162mg aspirin dose

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring aspirin, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

BMI < 30
already on ASA

Sites / Locations

The Ohio State Medical Center Labor and Delivery Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

81 mg daily aspirin dose

162mg daily aspirin dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Diagnosis of preeclampsia

by acog definitions

Secondary Outcome Measures

Incidence of aspirin resistance based on incomplete inhibition of TBx2

incomplete platelet inhibition measured by urinary TBx2

Full Information

NCT ID

NCT03735433

First Posted

November 4, 2018

Last Updated

May 10, 2023

Sponsor

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT03735433

Brief Title

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

Official Title

The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Suspended

Why Stopped

modification to protocol and futility

Study Start Date

January 15, 2019 (Actual)

Primary Completion Date

January 30, 2023 (Actual)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preeclampsia

Keywords

aspirin, obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

81 mg daily aspirin dose

Arm Type

No Intervention

Arm Description

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

Arm Title

162mg daily aspirin dose

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

162mg aspirin dose

Intervention Description

2 pills of 81mg aspirin

Primary Outcome Measure Information:

Title

Incidence of Diagnosis of preeclampsia

Description

by acog definitions

Time Frame

Through study completion, an average for 10 months

Secondary Outcome Measure Information:

Title

Incidence of aspirin resistance based on incomplete inhibition of TBx2

Description

incomplete platelet inhibition measured by urinary TBx2

Time Frame

Through study completion, an average for 10 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

pregnant women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI at enrollment >/= 30 plan for ASA for preeclampsia prevention Exclusion Criteria: BMI < 30 already on ASA

Facility Information:

Facility Name

The Ohio State Medical Center Labor and Delivery Unit

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs