Aspirin (ASA) Therapy and Preeclampsia Prevention

NCT04158830 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 19-06959-FB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

According to U.S. Pharmacist® "low-dose aspirin refers to dosages between 81 mg and 325 mg taken every day to prevent heart attacks, strokes, and colon cancer." It has been found through research that low-dose aspirin also decreases the risk of preeclampsia. The American College of Obstetrics and Gynecologists (ACOG) recommends low-dose aspirin (81mg/day) for women at high risk of preeclampsia. However, some researchers report that a dose of aspirin \< 100 mg/day does not seem to decrease the risk of preeclampsia. Another trial studying patients who are at a high risk for preterm preeclampsia, reported a reduction in the occurrence of preeclampsia among patients taking aspirin at a dose of 150 mg. The purpose of this pragmatic randomized study is to compare the difference in the effectiveness of two doses of aspirin: 81 mg versus 162 mg in the prevention of preeclampsia in pregnant women who are at a moderate to high risk for developing preeclampsia.

Conditions

Preeclampsia

Keywords

prevention; aspirin therapy

Outcome Measures

Primary Outcomes (1)

• Preeclampsia

  Occurrence of preeclampsia: categorized as - none, preterm, or term

  approximately 30 weeks; from 12 weeks gestation until the day of delivery

Study Arms (2)

Group 1 - ACOG recommended dose

OTHER

oral dose: 81 mg aspirin daily; designated by odd number assignment \[1-001, 1-003, 1-005, etc. to 899\]

Drug: Aspirin 81 mg Enteric Coated Tab - 1 tablet

Group 2 - Comparison Dose

ACTIVE COMPARATOR

oral dose: 162 mg aspirin daily; designated by even number assignment \[2-002, 2-004, 2-006, etc. to 900\]

Drug: Aspirin 81 mg Enteric Coated Tab - 2 tablets

Interventions

Aspirin 81 mg Enteric Coated Tab - 1 tablet DRUG

take one (1) 81 mg tablet each evening

Also known as: Group 1 - ACOG recommended dose

Group 1 - ACOG recommended dose

Aspirin 81 mg Enteric Coated Tab - 2 tablets DRUG

take two (2) 81 mg tablets each evening

Also known as: Group 2 - Comparison Dose

Group 2 - Comparison Dose

Eligibility Criteria

• Age: 14 Years - 50 Years
• Gender Eligibility Details: Pregnant women only
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant females ages 14 to 50 years old
• Up to 28.0 weeks gestation (may initially base on last menstrual period (LMP), but confirmed with ultrasound (US)
• Be at high risk or moderate risk for developing preeclampsia as defined by the American College of Obstetrics and Gynecologists (ACOG-2018), the Society for Maternal-Fetal Medicine (SMFM-2018), and the United States Preventive Services Task Force (USPSTF-2017)

You may not qualify if:

• Less than 14 years old or greater than 50 years old
• Allergy or contraindication to taking aspirin (i.e. nasal polyps, asthma with aspirin-induced bronchoconstriction)
• History of gastrointestinal bleeding
• Active peptic ulcer disease
• Other sources of active Gastrointestinal/Genitourinary bleeding
• Physician or provider refusal
• Patient refusal
• History of bleeding or clotting disorder (i.e. Factor V, von Willebrand, hemophilia)
• Severe renal failure (Glomerular Filtration Rate \< 10 ml/min)
• Taking aspirin prior to pregnancy

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Regional One Health, Obstetrics Outpatient Clinic

Memphis, Tennessee, 38103, United States

Location

Related Publications (8)

• Roberge S, Bujold E, Nicolaides KH. Aspirin for the prevention of preterm and term preeclampsia: systematic review and metaanalysis. Am J Obstet Gynecol. 2018 Mar;218(3):287-293.e1. doi: 10.1016/j.ajog.2017.11.561. Epub 2017 Nov 11.

  PMID: 29138036 BACKGROUND

• ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.

  PMID: 29939940 RESULT

• Lisonkova S, Joseph KS. Incidence of preeclampsia: risk factors and outcomes associated with early- versus late-onset disease. Am J Obstet Gynecol. 2013 Dec;209(6):544.e1-544.e12. doi: 10.1016/j.ajog.2013.08.019. Epub 2013 Aug 22.

  PMID: 23973398 RESULT

• Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15.

  PMID: 27640943 RESULT

• Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

  PMID: 28657417 RESULT

• Seidler AL, Askie L, Ray JG. Optimal aspirin dosing for preeclampsia prevention. Am J Obstet Gynecol. 2018 Jul;219(1):117-118. doi: 10.1016/j.ajog.2018.03.018. Epub 2018 Mar 26. No abstract available.

  PMID: 29588190 RESULT

• LeFevre ML; U.S. Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Dec 2;161(11):819-26. doi: 10.7326/M14-1884.

  PMID: 25200125 RESULT

• Lovgren TR, Dugoff L, Galan HL. Uterine artery Doppler and prediction of preeclampsia. Clin Obstet Gynecol. 2010 Dec;53(4):888-98. doi: 10.1097/GRF.0b013e3181fbb687.

  PMID: 21048456 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Giancarlo Mari, MD, FACOG

  OB/ GYN Department Professor and Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in consecutive order, entering their basic information (name, date of birth, medical record number, date/time of randomization, randomization number) on a master log. Group 1- (total of up to 450 subjects) designated by odd numbers in the randomization pattern \[1-001, 1-003, 1-005, etc. to 899\] oral dose: 81 mg aspirin daily: Rx 81 mg ASA, 1 tablet daily (1 bottle of 200 tablets/patient) Group 2-(total of up to 450 subjects) designated by even numbers in the randomization pattern \[2-002, 2-004, 2-006, etc. to 900\] oral dose: 162 mg aspirin daily: Rx 81 mg ASA, 2 tablets daily (1 bottle of 400 tablets/patient)

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 12, 2019
• Study Start: June 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)