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

NCT04908982 | Unknown Phase 4 FDA Drug

• 1 other identifier: AS1H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Preterm Preeclampsia

  Preeclampsia developed before 37 weeks

  Prior to 37 weeks

Secondary Outcomes (4)

• Preeclampsia

  After 37 weeks

• Gestational Hypertension

  After 20 weeks gestation

• HELLP Syndrome

  After 20 weeks gestation

• Eclampsia

  After 20 weeks gestation

Study Arms (2)

Aspirin

EXPERIMENTAL

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.

Drug: Aspirin 81mg

No Aspirin

NO INTERVENTION

Participants in this arm will receive no aspirin.

Interventions

Aspirin 81mg DRUG

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

Aspirin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• AMAG Pharmaceuticals, Inc.: collaborator

Study Sites (1)

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

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (24)

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  BACKGROUND

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MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tetsuya Kawakita, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tetsuya Kawakita, MD

CONTACT

7574467900; kawakit@evms.edu

Kristin Ayers, MPH

CONTACT

7574460579; ayerskl@evms.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Principal Investigator, Co-Investigators, and Sonographers will all be masked from knowledge of the intervention assigned to each participant. Participants and the Study Coordinator will not be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either receive 81mg of aspirin daily beginning between 12 and 16 weeks of pregnancy or to receive no aspirin.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: May 28, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 28, 2021

Record last verified: 2021-05

Locations

US (1)