162 mg of Aspirin for Prevention of Preeclampsia

Last updated: January 22, 2022
Sponsor: Methodist Medical Center of Illinois
Overall Status: Active - Recruiting

Phase

4

Condition

Preeclampsia

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT05221164
1732470-3
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 pregnancyoutcomes

Exclusion

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

Total Participants: 200
Study Start date:
July 06, 2021
Estimated Completion Date:
June 09, 2022

Study Description

After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia.

At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.

Connect with a study center

  • UnityPoint Clinic Family Medicine

    Peoria, Illinois 61602
    United States

    Active - Recruiting

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