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

Sponsor
Women and Infants Hospital of Rhode Island (Other)
Overall Status
Recruiting
CT.gov ID
NCT04797949
Collaborator
(none)
156
1
2
14.9
10.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low-dose aspirin
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients are randomized to receiving aspirin knowing their risk status vs those who are randomized to universal receipt.Patients are randomized to receiving aspirin knowing their risk status vs those who are randomized to universal receipt.
Masking:
Single (Outcomes Assessor)
Masking Description:
The study personnel who will perform pill counts will be masked to the study arm.
Primary Purpose:
Prevention
Official Title:
Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
Actual Study Start Date :
Mar 3, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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.

  4. Placental abruption [This will be measured from 20 weeks until 42 weeks.]

    Rates of placental abruption will be collected

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women and Infants Hospital Providence Rhode Island United States 02905

Sponsors and Collaborators

  • Women and Infants Hospital of Rhode Island

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sebastian Ramos, Principal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT04797949
Other Study ID Numbers:
  • 1581227
First Posted:
Mar 15, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
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
Keywords provided by Sebastian Ramos, Principal Investigator, Women and Infants Hospital of Rhode Island
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2021