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

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ClinicalTrials.gov Identifier: NCT03735433
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kara M Rood, MD, Ohio State University

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: 162mg aspirin dose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
No Intervention: 81 mg daily aspirin dose
obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA
Active Comparator: 162mg daily aspirin dose
obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA
Drug: 162mg aspirin dose
2 pills of 81mg aspirin




Primary Outcome Measures :
  1. Incidence of Diagnosis of preeclampsia [ Time Frame: Through study completion, an average for 10 months ]
    by acog definitions


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI < 30
  • already on ASA

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Ohio State University

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Responsible Party: Kara M Rood, MD, Prinicple Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT03735433     History of Changes
Other Study ID Numbers: OBASA
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Kara M Rood, MD, Ohio State University:
aspirin
obesity

Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pre-Eclampsia
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