Preeclampsia
Conditions
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.
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.
Interventions
DRUGAspirin 162 mg
Daily aspirin 162 mg during pregnancy to prevent preeclampsia
Sponsors
University of Illinois College of Medicine at Peoria
UICOM Peoria Family Medicine Residency
Methodist Medical Center of Illinois
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with preeclampsia | Through study completion, estimated 18 months | Dangerous pregnancy complication characterized by high blood pressure |
| Number of participants with eclampsia | Anytime during pregnancy and 3 months post partum | new onset of seizures in pregnant woman with preeclampsia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with aplastic anemia | Through study completion, estimated 18 months | deficiency of all blood cell lines |
| Number of participants with placental abruption | Through study completion, estimated 18 months | Separation of placenta from the uterus prior to delivery |
| Number of participants with anaphylaxis | Through study completion, estimated 18 months | serious allergic reaction |
| Number of participants with agranulocytosis | Through study completion, estimated 18 months | deficiency of granulocytes |
| Number of participants with post partum hemorrhage | Through study completion, estimated 18 months | blood loss after delivery |
Countries
United States
Outcome results
None listed