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

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

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• 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
• Last Update Posted: March 12, 2019
• Last Verified: March 2019

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

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

aspirin; obesity

Additional relevant MeSH terms:

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