162 mg of Aspirin for Prevention of Preeclampsia

January 22, 2022 updated by: Paul M Goldsmith, DO, Methodist Medical Center of Illinois
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Recruiting
        • UnityPoint Clinic Family Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Goldsmith, MD
        • Sub-Investigator:
          • Andras Eder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with preeclampsia
Time Frame: Through study completion, estimated 18 months
Dangerous pregnancy complication characterized by high blood pressure
Through study completion, estimated 18 months
Number of participants with eclampsia
Time Frame: Anytime during pregnancy and 3 months post partum
new onset of seizures in pregnant woman with preeclampsia
Anytime during pregnancy and 3 months post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with placental abruption
Time Frame: Through study completion, estimated 18 months
Separation of placenta from the uterus prior to delivery
Through study completion, estimated 18 months
Number of participants with post partum hemorrhage
Time Frame: Through study completion, estimated 18 months
blood loss after delivery
Through study completion, estimated 18 months
Number of participants with aplastic anemia
Time Frame: Through study completion, estimated 18 months
deficiency of all blood cell lines
Through study completion, estimated 18 months
Number of participants with agranulocytosis
Time Frame: Through study completion, estimated 18 months
deficiency of granulocytes
Through study completion, estimated 18 months
Number of participants with anaphylaxis
Time Frame: Through study completion, estimated 18 months
serious allergic reaction
Through study completion, estimated 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Medical Center of Illinois

Collaborators

University of Illinois College of Medicine at Peoria
UICOM Peoria Family Medicine Residency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2021

Primary Completion (Anticipated)

June 9, 2022

Study Completion (Anticipated)

June 9, 2022

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

January 22, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1732470-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD for statistical analysis and study report.

IPD Sharing Time Frame

After study completion for analysis and completion of final publication.

IPD Sharing Access Criteria

Statistician access.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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