Recruiting

Aspirin

Sponsor:

Methodist Medical Center of Illinois

Code:

NCT05221164

Conditions

Preeclampsia

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Aspirin 162 mg

Study Details

Brief summary:

This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.

Conditions

Preeclampsia

Study ID

NCT05221164

Start date

Jul 6, 2021

Status verified date

Jan, 2022

Completion date

Jun 9, 2022

Anticipated

Primary completion date

Jun 9, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Any pregnant patient at Peoria FMC
  • Hx of pre-eclampsia
  • Multifetal gestation
  • Chronic hypertension
  • Type 1 or 2 diabetes
  • Autoimmune disease
  • Renal disease
  • Nulliparity
  • Obesity
  • Family Hx of pre-eclampsia
  • Sociodemographic characteristics
  • Age >= 35 years of age
  • Personal history factors (LBW, SGA, > 10-year pregnancy interval, adverse pregnancy outcomes

Exclusion Criteria:

  • At high risk of side effects from ASA therapy
  • Hx of hemorrhagic stroke
  • Hx of GI bleed, G6PD
  • Liver disease
  • NSAID or Salicylate allergy)
  • Patients confirmed to be not compliant with therapy

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention with 162 mg aspirin

Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic

Interventions

Aspirin 162 mg

Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Primary outcome measure

  • Number of participants with preeclampsia [ Time Frame: Through study completion, estimated 18 months ]
  • Number of participants with eclampsia [ Time Frame: Anytime during pregnancy and 3 months post partum ]

Central Contacts and Locations

Locations

UnityPoint Clinic Family Medicine

Recruiting

Peoria, Illinois, United States, 61602

Contacts

Paul Goldsmith, MD

816-838-8335paul.goldsmith@unitypoint.org

Andras Eder, MD

619-995-2529andras.eder@unitypoint.org

Principal Investigator:

Paul Goldsmith, MD

More Information

Sponsor

Methodist Medical Center of Illinois

Last update posted

Feb 2, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Medical Center of Illinois on 2022-02-02.