The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03735433 |
Recruitment Status :
Recruiting
First Posted : November 8, 2018
Last Update Posted : March 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Preeclampsia | Drug: 162mg aspirin dose | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia |
Actual Study Start Date : | January 15, 2019 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | January 2022 |
Arm | Intervention/treatment |
---|---|
No Intervention: 81 mg daily aspirin dose
obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA
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Active Comparator: 162mg daily aspirin dose
obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA
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Drug: 162mg aspirin dose
2 pills of 81mg aspirin |
- Incidence of Diagnosis of preeclampsia [ Time Frame: Through study completion, an average for 10 months ]by acog definitions
- Incidence of aspirin resistance based on incomplete inhibition of TBx2 [ Time Frame: Through study completion, an average for 10 months ]incomplete platelet inhibition measured by urinary TBx2

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | pregnant women |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI at enrollment >/= 30
- plan for ASA for preeclampsia prevention
Exclusion Criteria:
- BMI < 30
- already on ASA

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735433
United States, Ohio | |
The Ohio State Medical Center Labor and Delivery Unit | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Kara Rood, MD 440-321-0264 kara.rood@osumc.edu | |
Contact: Anna Barthlomew, RN 614-293-5632 anna.barthlomew@osumc.edu | |
Principal Investigator: Kara M Rood, MD |
Responsible Party: | Kara M Rood, MD, Prinicple Investigator, Ohio State University |
ClinicalTrials.gov Identifier: | NCT03735433 |
Other Study ID Numbers: |
OBASA |
First Posted: | November 8, 2018 Key Record Dates |
Last Update Posted: | March 2, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
aspirin obesity |
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |