Pharmaceutical Regulatory Affairs

Biography

Biography: Rajiv Mahendru

Abstract

Objective: For assessment of effects of supplementation of antioxidant lycopene in antenatal cases considered high risk candidates for pregnancy induced hypertension (P.I.H) and/or fetal growth restriction. Materials & Methods: A pilot study comprising 107 pregnant women between 13 and 28 gestational weeks with factors considered high risk for developing pre-eclampsia were considered and randomly allocated into two groups: I (n=55) and II (n=52), with orwithout lycopene supplementation, respectively. Lycopene in a dose of 4 mg once daily starting from the date of entry was given to the antenatal subjects of the study group (Group-I) and were instructed to continue the drug regularly until delivery. Women of the other group (Group-II) were not provided with lycopene supplementation. Main observation measures considered were whether there was development of preeclampsia and its severity, period of gestation at delivery, mode of delivery, fetal weight and perinatal outcome as regards to admission to neonatal intensive care unit and neonatal death. Observations: There were no signicant differences in development of preeclampsia in both the groups but severity was more in the group-II where patients did not receive lycopene. Significant adverse finding noticed, having no mention in the literature earlier, was: one case of eclampsia. Women in the lycopene supplementation group had not only signicantly lesser incidence of growth restricted babies but also signicantly healthier babies and had a signicantly better perinatal outcome compared to women in non- supplementedgroup. Conclusion: Supplementation of lycopene although does not decrease the incidence of preeclampsia in high risk women but may help in reducing its severity and there is reduced incidence of intrauterine growth restriction with better prenatal outcome.