Recruiting

Aspirin

Sponsor:

Eastern Virginia Medical School

Code:

NCT04908982

Conditions

Pre-Eclampsia

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Aspirin 81mg

Study Details

Brief summary:

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.

Conditions

Pre-Eclampsia

Study ID

NCT04908982

Start date

May 28, 2021

Status verified date

May, 2021

Completion date

May 31, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant women from 6 0/7 to 13 6/7 weeks gestation
  • 18-50 years old
  • Systolic blood pressure of 130-139 mmHg or Diastolic blood pressure of 80-89 mmHg

Exclusion Criteria:

  • History of preeclampsia
  • Multifetal gestation
  • Chronic hypertension
  • Pre-gestational diabetes
  • Renal disease
  • Autoimmune disease
  • Aspirin allergy or hypersensitivity
  • Presence of nasal polyps
  • History of aspirin-induced bronchospasm

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Aspirin

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.

no intervention: No Aspirin

Participants in this arm will receive no aspirin.

Interventions

Aspirin 81mg

81mg aspirin daily beginning between 12 and 16 weeks of pregnancy and continuing until delivery.

Primary outcome measure

  • Preterm Preeclampsia [ Time Frame: Prior to 37 weeks ]

Central Contacts and Locations

Central contacts

Tetsuya Kawakita, MD

7574467900kawakit@evms.edu

Kristin Ayers, MPH

7574460579ayerskl@evms.edu

Locations

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Tetsuya Kawakita, MD

757-446-7900kawakit@evms.edu

Kristin Ayers, MPH

7574460579ayerskl@evms.edu

Principal Investigator:

Tetsuya Kawakita, MD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Jun 28, 2021

Last verified

May, 2021

Keywords

  • Preeclampsia
  • Hypertension
  • Stage 1 Hypertension
  • Pregnancy
  • Aspirin
  • Low Dose Aspirin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2021-06-28.