Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension

Recruiting in Palo Alto (17 mi)

Overseen byTetsuya Kawakita, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Eastern Virginia Medical School

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P \<0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.

Research Team

Tetsuya Kawakita, MD

Principal Investigator

Eastern Virginia Medical School

Eligibility Criteria

Inclusion Criteria

You must be between 18 and 50 years old.

Pregnant women from 6 0/7 to 13 6/7 weeks gestation

Systolic blood pressure of 130-139 mmHg or Diastolic blood pressure of 80-89 mmHg

Exclusion Criteria

You have experienced breathing difficulties after taking aspirin in the past.

Presence of nasal polyps

You have a history of a pregnancy complication called preeclampsia.

See 6 more

Treatment Details

Interventions

Aspirin (Nonsteroidal Anti-inflammatory Drug)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: AspirinExperimental Treatment1 Intervention

Participants in this arm will be instructed to take 1 81mg aspirin daily beginning between weeks 12 and 16 of pregnancy and continuing until delivery.

Group II: No AspirinActive Control1 Intervention

Participants in this arm will receive no aspirin.

Aspirin is already approved in Canada, China for the following indications: