Trial of lycopene to prevent pre-eclampsia in healthy primigravidas: Results show some adverse effects

Aim: To evaluate the efficacy of antioxidant lycopene in preventing pre-eclampsia in healthy primigravidas. Methods: A prospective randomized double blind placebo-controlled study was undertaken with informed written consent. A total of 159 primigravidas at gestational ages between 12 and 20 weeks, with singleton pregnancy and without any medical disorders were enrolled. Seventy-seven (subjects) of these women received 2 mg oral lycopene daily and 82 (controls) received a placebo daily until delivery. The women were followed up until delivery for the development of pre-eclampsia and maternal, fetal and neonatal outcomes. Results: The two study groups of healthy primigravidas (one receiving lycopene and the other placebo) were of similar physical and social parameters. The investigation showed no significant difference between the two groups in developing pre-eclampsia (18.18% with lycopene vs 18.29% with placebo, P value = 0.99). On the contrary, there was a significantly higher incidence of adverse effects like preterm labor (10.39% with lycopene vs 1.22% with placebo, P value = 0.02) and low birthweight (<2.5 kg) babies (22.08% with lycopene vs 9.76% with placebo, P value = 0.05). Conclusion: The results of the present study indicate that the antioxidant lycopene has no benefit in prevention of pre-eclampsia in healthy primigravidas. Rather, there is an increased incidence of the adverse effects of preterm labor and low birthweight babies.