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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03735433
• Other study ID #: OBASA
• Status: Terminated
• Phase: Phase 4
• Start date: January 15, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: March 1, 2024
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• BMI < 30
• already on ASA

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• 162mg aspirin dose
2 pills of 81mg aspirin

Locations

Country	Name	City	State
United States	The Ohio State Medical Center Labor and Delivery Unit	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Diagnosis of Preeclampsia	by acog definitions	Through study completion, an average for 10 months
Secondary	Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2	incomplete platelet inhibition measured by urinary TBx2	Through study completion, an average for 10 months