Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia

Women and Infants Hospital of Rhode Island

Status and phase: Withdrawn; Phase 4

Conditions: Preeclampsia; Medication Adherence

Treatments: Drug: Low-dose aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04797949

1581227

Details and patient eligibility

About

There are data showing that a majority of pregnant women may not be accurately identified as high risk through screening and therefore, not receiving prophylactic low dose aspirin as recommended. This leads to missing many patients who would benefit from aspirin administration. Aspirin is an effective, affordable and safe intervention and its universal use in pregnancy has been proposed as the answer to help mitigate risk of significant morbidity from preeclampsia. However, adherence to aspirin in women at low risk compared to those deemed at high risk of preeclampsia has never been studied. One of the arguments against universal aspirin administration is the concern that universal receipt would change the compliance in those at high risk although there are no data to support this concern. To address the lack of data on differences in adherence, our goal in this proposal is to assess whether there is a difference in adherence to low dose aspirin (81 mg) in women at high risk of preeclampsia as indicated by USPSTF risk algorithm when compared to those women randomized to universal use.

Full description

Research objective- To compare adherence to low dose, 81mg of aspirin in women considered high risk by USPSTF criteria vs universal receipt.

Hypothesis: Women considered high risk by USPSTF criteria will have better adherence to low dose aspirin than women randomized to universal receipt.

Study Design: Randomized trial

Population: English or Spanish speaking women between 10-20 weeks of gestation receiving their care at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital

Once enrolled, patients will then be randomized to USPSTF criteria to determine if they qualify for aspirin or to universal aspirin receipt. Once randomized, patients will undergo video pill counts at multiple intervals in their prenatal care (monthly).

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnancy between 10 to 20 weeks gestation by best available dating
• 18 years of age or older
• Fluency in English or Spanish

Exclusion criteria

• Contraindication to aspirin use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Randomized to USPSTF Criteria

Active Comparator group

Description:

Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin.

Treatment:

Drug: Low-dose aspirin

Randomized to Universal aspirin receipt

Active Comparator group

Description:

Women randomized to receiving low dose aspirin without knowing their risk status.

Treatment:

Drug: Low-dose aspirin