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

Phase 4

Withdrawn

• Conditions: Medication Adherence; Preeclampsia
• Interventions: Drug: Low-dose aspirin

• Registration Number: NCT04797949
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2021-02-08
• Study Start: 2021-03-03
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized to USPSTF Criteria	Low-dose aspirin	Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin.
Randomized to Universal aspirin receipt	Low-dose aspirin	Women randomized to receiving low dose aspirin without knowing their risk status.

Primary Outcome Measures

Name	Time	Method
Adherence to aspirin use	up to 42 weeks.	A Research Coordinator will contact each patient within 7 days of recruitment to assure the patient has picked up and has their prescription with subsequent contacts occurring at 30-day intervals until delivery.

Secondary Outcome Measures

Name	Time	Method
Rates of preeclampsia	Rates of hypertensive disease of pregnancy will be measured from 20 weeks of gestation until 6 weeks postpartum	We will measure rates of hypertensive disease of pregnancy
Fetal growth restriction	This will be measured from 24 weeks until 39 weeks.	We will measure rates of fetal growth restriction defined as estimated fetal weight or abdominal circumference \<10%ile.
Placental abruption	This will be measured from 20 weeks until 42 weeks.	Rates of placental abruption will be collected
Rates of postpartum hemorrhage	These will be assessed within 24 hours after delivery.	We will collect information at time of delivery of rates of postpartum hemorrhage defined as estimated blood loss of 1000 cc or greater.

Trial Locations

Locations (1)

Women and Infants Hospital; 🇺🇸 Providence, Rhode Island, United States