Ramalingappa Antartani1, Kiran Ashok2. 1. Department of Obstetrics and Gynecology, Karnataka Institute of Medical Sciences, Hubli, India. 2. Helios Clinics, Schwerin, Germany.
Abstract
OBJECTIVE: To evaluate the effect of pre-natal supplementation of antioxidant Lycopene in prevention of pre-eclampsia in the high risk pregnant women. We also assessed the effect of lycopene supplementation on intra-uterine growth restriction and the perinatal outcome in women at high risk of developing pre-eclampsia. MATERIALS AND METHODS: A total of 54 women between 14-28 weeks of pregnancy who were at high risk of developing pre-eclampsia were considered for the study. Inclusion criteria were women with a previous history of preeclampsia, a growth-retarded fetus, perinatal death, multifetal gestation and chronic hypertension. Of the total of 54 women, 30 women were randomized to receive Lycopene in a dose of 2 mg twice daily starting from the date of entry and were instructed to continue the drug regularly until delivery. The other 24 women were randomized to the control group and they did not take lycopene. The controls were matched to cases with respect to the risk factors for the development of preeclampsia. Both groups were followed at monthly intervals. In addition, a Doppler assessment for evidence of intrauterine growth retardation was done at around 28 wks of gestation. Data regarding development of preeclampsia, period of gestation during delivery, mode of delivery, fetal weight and perinatal outcome were recorded and subjected to statistical analysis. RESULTS: Of the 30 women randomized to receive the drug, ten women were lost to follow-up. Thus only 20 women in the treatment group completed the study. All the 24 women in the control group completed the study. Lycopene was not found to decrease the incidence of pre-eclampsia in high risk women. Women in the lycopene supplementation group had significantly lesser incidence of growth restricted babies and had a significantly better perinatal outcome compared to women in the placebo group. CONCLUSION:Lycopene supplementation does not decrease the incidence of preeclampsia in high risk women. However lycopene supplementation does seem to help in reducing the incidence of intra-uterine growth restriction.
RCT Entities:
OBJECTIVE: To evaluate the effect of pre-natal supplementation of antioxidant Lycopene in prevention of pre-eclampsia in the high risk pregnant women. We also assessed the effect of lycopene supplementation on intra-uterine growth restriction and the perinatal outcome in women at high risk of developing pre-eclampsia. MATERIALS AND METHODS: A total of 54 women between 14-28 weeks of pregnancy who were at high risk of developing pre-eclampsia were considered for the study. Inclusion criteria were women with a previous history of preeclampsia, a growth-retarded fetus, perinatal death, multifetal gestation and chronic hypertension. Of the total of 54 women, 30 women were randomized to receive Lycopene in a dose of 2 mg twice daily starting from the date of entry and were instructed to continue the drug regularly until delivery. The other 24 women were randomized to the control group and they did not take lycopene. The controls were matched to cases with respect to the risk factors for the development of preeclampsia. Both groups were followed at monthly intervals. In addition, a Doppler assessment for evidence of intrauterine growth retardation was done at around 28 wks of gestation. Data regarding development of preeclampsia, period of gestation during delivery, mode of delivery, fetal weight and perinatal outcome were recorded and subjected to statistical analysis. RESULTS: Of the 30 women randomized to receive the drug, ten women were lost to follow-up. Thus only 20 women in the treatment group completed the study. All the 24 women in the control group completed the study. Lycopene was not found to decrease the incidence of pre-eclampsia in high risk women. Women in the lycopene supplementation group had significantly lesser incidence of growth restricted babies and had a significantly better perinatal outcome compared to women in the placebo group. CONCLUSION:Lycopene supplementation does not decrease the incidence of preeclampsia in high risk women. However lycopene supplementation does seem to help in reducing the incidence of intra-uterine growth restriction.
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