Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
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 |
|---|---|---|
|
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
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
- 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
- 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.
- 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
Eligibility Criteria
Criteria
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.- 1581227