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

MFMU Network Randomized Clinical Trial of Low-Dose
Aspirin as a Preventative of Preeclampsia

Related Publications & Presentations

Objective

To establish whether daily administration of low-dose (60 mg) aspirin to nulliparous obstetrical patients will decrease the incidence of preeclampsia.

Conclusion

The trial concluded that low-dose aspirin marginally decreased the incidence of preeclampsia among nulliparous women (4.6% vs 6.3%, p=0.05), but increased the risk of abruptio placentae and did not improve overall perinatal morbidity.

Clinical Centers

Johns Hopkins, Magee Womens, Columbia, Tennessee, Thomas Jefferson U., LAC/USC. Yale

Major Eligibility Criteria

• Nulliparous
• 13-26 weeks gestation
• BP < 135/85 w/o antihypertensive meds
• No aspirin meds during prior 2 weeks
• None or trace proteinuria
• Compliance with placebo run-in

Groups

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

Sample Size

• Goal = 3,000 (1500/year)

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=3135): 3/89 - 9/91
• Follow-up: Thru - 3/92