Preeclampsia Clinical Trial
Official title:
Comparison of Two Doses (81 mg Versus 162 mg) of Aspirin for the Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women: A Randomized Controlled Trial
Preeclampsia is a pregnancy-specific syndrome that affects 3 - 5% of pregnancies. It is one
of the main causes of maternal, fetal and neonatal morbidity and mortality, resulting in
approximately 40,000 maternal deaths worldwide each year. Fortunately, preeclampsia-related
deaths have been reduced remarkably in recent decades thanks to improvements in antenatal
care and therapeutic interventions, and prophylactic use of low-dose aspirin in women who are
at a higher risk of developing preeclampsia.
Effective prevention is rarely available for obstetric complications. Aspirin is one of them.
Several meta-analyses456 suggested that aspirin prescription reduced the risk of preeclampsia
and fetal growth restriction by 40-50% in an aspirin-dose-response pattern.
Preterm preeclampsia is an important cause of maternal and perinatal death and complications.
It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of
preterm preeclampsia.
In a meta-analysis of individual-participant data from the trials, the effect of aspirin was
not affected by the gestational age at the onset of therapy. In contrast, other meta-analyses
showed that aspirin started at or before 16 weeks of gestation resulted in halving the rates
of preeclampsia, fetal growth restriction, and perinatal death, whereas aspirin started after
16 weeks of gestation did not have a significant benefit. In addition, the beneficial effect
of aspirin that was started at or before 16 weeks of gestation was dose-dependent, with a
greater reduction in the incidence of preeclampsia being associated with a daily dose of
aspirin of 100 mg or more.
This will be a randomized control trial to estimate the efficacy of two doses (81 mg versus
162 mg) of aspirin for prevention of preeclampsia in healthy, nulliparous obese and
overweight pregnant women identified in the first trimester.
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