162 mg of Aspirin for Prevention of Preeclampsia

Methodist Medical Center of Illinois

Status and phase: Unknown; Phase 4

Conditions: Preeclampsia

Treatments: Drug: Aspirin 162 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05221164

1732470-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intervention with 162 mg aspirin

Experimental group

Description:

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

Treatment:

Drug: Aspirin 162 mg