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IRCT201108157334N1 IRCT 2012-10-08 Vice chancellor for research of Tehran University of Medical Sciences Efficacy of Isosorbide dinitrate in cervical ripening A comparision of out patient oral and vaginal Isosorbide dinitrate in cervical ripening befor induction of labor in post term pregnancy with low bishop score 2012-03-19 anticipated 150 Complete https://irct.ir/trial/7780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Isosorbide dinitrate effect on cervical ripening. Intervention 1: Samples of investigation are divided into three groups based on randomly numbers table., in one group isosorbide dinitrate 40 mg should be placed vaginaly in posterior fornix.The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor.THE induction starts with2.5mIU/min of 10 unit oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time is measured. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day Also, if headache is occures after administration of ISDN, patient should be given acetaminophen. . Intervention 2: Samples of investigation are divided into three groups based on randomly numbers table., in one group isosorbide dinitrate20 mg should be given oraly.The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor.THE induction starts with2.5mIU/min of 10 mg oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time MEASURE. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day Also, if the headache is detect after administration of ISDN shuld given acetaminophen. . Intervention 3: Samples of investigation are divided into three groups based on randomly numbers tablethat one group is control.they dont take any drug.The Bishop score is determined at the beginning of the study.THE induction starts with2.5mIU/min of 10 mg oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time is measured. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day.
public Dr Ladan Haghighi
Enghelab street -tehran university
Tehran Iran (Islamic Republic of) +98 21 66111 l-haghighi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Ladan Haghighi
Enghelab street -Tehran university
Tehran Iran (Islamic Republic of) +98 21 66111 l-haghighi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1)Nulliparity 2)Gestational age>42 weeks 3)Bishop score<5 4)Singleton pregnancy 5)Cephalic presentation 6) filled Consent form. Exclusion criteria: 1)Premature rupture of membrane 2)Vaginal bleeding 3)Contraindication for ISDN 4)History of any uterian scar 5)Intolerance to ISDN 6)Any systemic disease 7)Laber pain 8)Oligohydramnios 9)IUGR 10)Non-reassuring FHR 10 years 50 years Female P08 Disorders related to long gestation and high birth weight Treatment - Drugs Treatment - Drugs Treatment - Drugs Samples of investigation are divided into three groups based on randomly numbers table., in one group isosorbide dinitrate 40 mg should be placed vaginaly in posterior fornix.The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor.THE induction starts with2.5mIU/min of 10 unit oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time is measured. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day Also, if headache is occures after administration of ISDN, patient should be given acetaminophen. . Samples of investigation are divided into three groups based on randomly numbers table., in one group isosorbide dinitrate20 mg should be given oraly.The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor.THE induction starts with2.5mIU/min of 10 mg oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time MEASURE. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day Also, if the headache is detect after administration of ISDN shuld given acetaminophen. . Samples of investigation are divided into three groups based on randomly numbers tablethat one group is control.they dont take any drug.The Bishop score is determined at the beginning of the study.THE induction starts with2.5mIU/min of 10 mg oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time is measured. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day. Cervical ripening. Timepoint: 24 hours. Method of measurement: Vaginal exam. Time from full dilatation to delivery. Timepoint: Stage 2 of labor. Method of measurement: Minut. Time from active phase to full dilation. Timepoint: Stage 1 of labor. Method of measurement: Minut. From induction to active phase. Timepoint: active phase. Method of measurement: minut. Vice chancellor for research of Tehran University of Medical Sciences Approved 2012-01-16 Tehran University of Medical Sciences Ethics Committee Tehran University of Medical Sciences, Enghelab st. Tehran Iran (Islamic Republic of)