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

NCT03735433 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: OBASA
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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

Conditions

Preeclampsia

Keywords

aspirin; obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of Diagnosis of Preeclampsia

  by acog definitions

  Through study completion, an average for 10 months

Secondary Outcomes (1)

• Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2

  Through study completion, an average for 10 months

Study Arms (2)

81 mg daily aspirin dose

NO INTERVENTION

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

162mg daily aspirin dose

ACTIVE COMPARATOR

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

Drug: 162mg aspirin dose

Interventions

162mg aspirin dose DRUG

2 pills of 81mg aspirin

162mg daily aspirin dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• BMI \< 30
• already on ASA

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State Medical Center Labor and Delivery Unit

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Obesity

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kara Rood, MD
• Organization: The Ohio State University

Kara.Rood@osumc.edu

614-293-8515

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicple Investigator

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 8, 2018
• Study Start: January 15, 2019
• Primary Completion: January 30, 2023
• Study Completion: March 1, 2024
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)