National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

Randomized Clinical Trial of Low-Dose Aspirin to
Prevent Preeclampsia in High Risk Women

Related Publications & Presentations

Objective

To establish whether daily administration of low-dose (60 mg) aspirin to four groups of obstetrical patients at high risk for the development of preeclampsia will decrease incidence of preeclampsia.

Conclusion

Low-dose aspirin did not reduce the incidence of proteinuric hypertension significantly or improve perinatal outcomes (preterm birth, fetal growth restriction or bleeding complications) in pregnant women at high risk (insulin dependent diabetes, chronic hypertension, multifetal gestation or preeclampsia in a a previous pregnancy) for preeclampsia.

Clinical Centers

Magee Womens, Tennessee, Southern California, Alabama, Wayne State, Cincinnati, Oklahoma, Bowman Gray, Chicago, Ohio State, South Carolina

Major Eligibility Criteria

• Risk Groups:
• IDDM (antedating pregnancy)
• Chronic hypertension
• Multifetal pregnancy
• Previous preeclampsia
• 13-26 weeks gestation
• Compliance with placebo run-in period
• Informed consent

Groups

• Experimental = 60 mg aspirin (daily)
• Placebo = 60 mg placebo (daily)

Sample Size

• Goal = 2600 (1300/group)

Management Protocols

• Coded medication: 60 mg once daily up to delivery
• Coded medication discontinued: Development of preeclampsia
• Preeclampsia: Suggested guidelines for outpatient management
• BP Measurement: Standardized method
• Urine Protein: Standardized method

Outcome Measures

• Primary:
• Preeclampsia:
• Mild preeclampsia
• Severe preeclampsia
• Eclampsia
• HELLP syndrome
• Secondary:
• Mild and severe Pregnancy Induced Hypertension
• Adverse effects of aspirin

Timetable

• Randomization (n=2539): 5/91 - 6/95
• Follow-up: Thru - 10/96