Clinical trial

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

Name
OBASA
Description
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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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.
Trial arms
Trial start
2019-01-15
Estimated PCD
2023-01-30
Trial end
2024-03-01
Status
Terminated
Phase
Early phase I
Treatment
162mg aspirin dose
2 pills of 81mg aspirin
Arms:
162mg daily aspirin dose
Size
152
Primary endpoint
Incidence of Diagnosis of Preeclampsia
Through study completion, an average for 10 months
Eligibility criteria
Inclusion Criteria: * BMI at enrollment \>/= 30 * plan for ASA for preeclampsia prevention Exclusion Criteria: * BMI \< 30 * already on ASA
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 152, 'type': 'ACTUAL'}}
Updated at
2024-04-29

1 organization

1 product

1 indication

Product
Aspirin
Indication
Preeclampsia