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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797949
• Other study ID #: 1581227
• Status: Recruiting
• Phase: Phase 4
• Start date: March 3, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2021
• Source: Women and Infants Hospital of Rhode Island
• Contact: Sebastian Z Ramos, MD
• Phone: 401-452-0027
• Email: seramos[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Low-dose aspirin
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.

Locations

Country	Name	City	State
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (5)

Ayala NK, Rouse DJ. A Nudge Toward Universal Aspirin for Preeclampsia Prevention. Obstet Gynecol. 2019 Apr;133(4):725-728. doi: 10.1097/AOG.0000000000003167. — View Citation

Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 May 20; — View Citation

Mone F, Mulcahy C, McParland P, Breathnach F, Downey P, McCormack D, Culliton M, Stanton A, Cody F, Morrison JJ, Daly S, Higgins J, Cotter A, Hunter A, Tully EC, Dicker P, Alfirevic Z, Malone FD, McAuliffe FM. Trial of feasibility and acceptability of rou — View Citation

Shanmugalingam R, Wang X, Motum P, Fulcher I, Lee G, Kumar R, Hennessy A, Makris A. Clinical Influence of Nonadherence With Prophylactic Aspirin in Preventing Preeclampsia in High-Risk Pregnancies: A Multicenter, Prospective, Observational Cohort Study. H — View Citation

Werner EF, Hauspurg AK, Rouse DJ. A Cost-Benefit Analysis of Low-Dose Aspirin Prophylaxis for the Prevention of Preeclampsia in the United States. Obstet Gynecol. 2015 Dec;126(6):1242-1250. doi: 10.1097/AOG.0000000000001115. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to aspirin use	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	Rates of postpartum hemorrhage	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.
Secondary	Rates of preeclampsia	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
Secondary	Fetal growth restriction	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.
Secondary	Placental abruption	Rates of placental abruption will be collected	This will be measured from 20 weeks until 42 weeks.