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IRCT201602163027N33 IRCT 2016-04-08 Vice Chancellor Of Research of Tabriz University of Medical Sciences The effect of garlic tablet on plasma nitric oxide levels and prevention of preeclampsia in healthy nulliparous women: A randomized controlled trial The effect of garlic tablet on plasma nitric oxide levels and prevention of preeclampsia in healthy nulliparous women: A randomized controlled trial 2016-05-21 anticipated 400 Complete https://irct.ir/trial/3004 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Supervision of normal first pregnancy for prevention of preeclampsia. Intervention 1: Intervention group: Garlic tablet, 400 milligram, oral, every 12 hours 1 tablet for 16 weeks. Intervention 2: Control group: Placebo, oral, quite similar to garlic tablet, every 12 hours 1 tablet for 16 weeks.
public Shafaie Sehhatie Fahimeh
Faculty of Nursing and Midwifery, Shariati Ave, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 sehhatief@tbzmed.ac.ir Faculty of Nursing and Midwifery scientific Shafaie Sehhatie Fahimeh
Faculty of Nursing and Midwifery, Shariati Ave, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 sehhatief@tbzmed.ac.ir Faculty of Nursing and Midwifery Iran (Islamic Republic of) Inclusion criteria: Having ultrasound based on singleton pregnancy and baby health, 20 weeks pregnancy (according to gestational age in the early pregnancy ultrasound), pregnant women 18-35 years, failure to alcohol and tobacco, having at least read and write, having telephone number for follow-up Exclusion criteria: Systemic diseases such as diabetes mellitus, heart disease, kidney and... according to pregnant women statement, history of clotting disorders, history of hypertension disorder before pregnancy and during current pregnancy, body mass index equal to or greater than 30 kilograms per square meter, systolic blood pressure lower than 100 mmhg, history of allergy to garlic according to pregnant women statement, intake garlic more than 1 serving a day or more than 10 serving per week, participate in other similar studies. 18 years 35 years Female Z34.0 Supervision of normal first pregnancy Prevention Prevention Intervention group: Garlic tablet, 400 milligram, oral, every 12 hours 1 tablet for 16 weeks Control group: Placebo, oral, quite similar to garlic tablet, every 12 hours 1 tablet for 16 weeks Plasma nitric oxide level. Timepoint: 12 weeks after intervention. Method of measurement: Nitric oxide kit. The frequency of preeclampsia incidence. Timepoint: Before intervention, 6-10,11-14, 15-17 and 18-20 weeks after intervention. Method of measurement: The blood pressure according to millimeter of mercury using a mercury sphygmomanometer and random urine albumin using diagnostic strips for urine protein assay. The frequency of side events incidence. Timepoint: 8 and 16 weeks after intervention. Method of measurement: The side events check list. Neonatal anthropometric indexes. Timepoint: After the termination of pregnancy. Method of measurement: Growth monitoring card. The frequency of preterm delivery incidence. Timepoint: During 16 weeks after intervention. Method of measurement: The folder summary sheet in Health centers. The patients satisfaction level of received drug. Timepoint: 8 and 16 weeks after intervention. Method of measurement: The check list of satisfaction of received drug. Vice Chancellor Of Research of Tabriz University of Medical Sciences Approved 2016-02-01 Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor Of Research, Number 2 Central Building, Tabriz University of Medical Sciences, Golgasht ave, Tabriz, Iran Tabriz Iran (Islamic Republic of)