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162 mg of Aspirin for Prevention of Preeclampsia

Sponsor
Methodist Medical Center of Illinois (Other)
Overall Status
Recruiting
CT.gov ID
NCT05221164
Collaborator
University of Illinois College of Medicine at Peoria (Other), UICOM Peoria Family Medicine Residency (Other)
200
Enrollment
1
Location
1
Arm
11.1
Anticipated Duration (Months)
18
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin 162 mg
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
162 mg of Aspirin for Prevention of Preeclampsia
Actual Study Start Date :
Jul 6, 2021
Anticipated Primary Completion Date :
Jun 9, 2022
Anticipated Study Completion Date :
Jun 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention with 162 mg aspirin

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

Drug: Aspirin 162 mg
Daily aspirin 162 mg during pregnancy to prevent preeclampsia
Other Names:
  • Aspirin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with preeclampsia [Through study completion, estimated 18 months]

      Dangerous pregnancy complication characterized by high blood pressure

    2. Number of participants with eclampsia [Anytime during pregnancy and 3 months post partum]

      new onset of seizures in pregnant woman with preeclampsia

    Secondary Outcome Measures

    1. Number of participants with placental abruption [Through study completion, estimated 18 months]

      Separation of placenta from the uterus prior to delivery

    2. Number of participants with post partum hemorrhage [Through study completion, estimated 18 months]

      blood loss after delivery

    3. Number of participants with aplastic anemia [Through study completion, estimated 18 months]

      deficiency of all blood cell lines

    4. Number of participants with agranulocytosis [Through study completion, estimated 18 months]

      deficiency of granulocytes

    5. Number of participants with anaphylaxis [Through study completion, estimated 18 months]

      serious allergic reaction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UnityPoint Clinic Family Medicine Peoria Illinois United States 61602

    Sponsors and Collaborators

    • Methodist Medical Center of Illinois
    • University of Illinois College of Medicine at Peoria
    • UICOM Peoria Family Medicine Residency

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paul M Goldsmith, DO, Resident Physician, Methodist Medical Center of Illinois
    ClinicalTrials.gov Identifier:
    NCT05221164
    Other Study ID Numbers:
    • 1732470-3
    First Posted:
    Feb 2, 2022
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Aspirin

    Study Results

    No Results Posted as of Feb 2, 2022