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

July 16, 2021 updated by: Sebastian Ramos, Women and Infants Hospital of Rhode Island
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Randomized to USPSTF Criteria
Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin.
Drug: Low-dose aspirin
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.
Active Comparator: Randomized to Universal aspirin receipt
Women randomized to receiving low dose aspirin without knowing their risk status.
Drug: Low-dose aspirin
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to aspirin use
Time Frame: 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.
up to 42 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of postpartum hemorrhage
Time Frame: 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.
These will be assessed within 24 hours after delivery.
Rates of preeclampsia
Time Frame: 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
Rates of hypertensive disease of pregnancy will be measured from 20 weeks of gestation until 6 weeks postpartum
Fetal growth restriction
Time Frame: 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.
This will be measured from 24 weeks until 39 weeks.
Placental abruption
Time Frame: This will be measured from 20 weeks until 42 weeks.
Rates of placental abruption will be collected
This will be measured from 20 weeks until 42 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Sebastian Z Ramos, MD, Women and Infants Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1581227

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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