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IRCT20120428009576N4 IRCT 2020-02-03 Qazvin University of Medical Sciences comparative evaluation of the effect of misoprostol vaginal suppository to vaginal misoprostol with nitroglycerine in rippening of cervix in term pregnancy reffered to kowsar hospital comparative evaluation of the effect of vaginal misoprostol to vaginal misoprostol with nitroglycerine in cervix rippening in pregnant women at term referred to Kowsar hospital of Qazvin province 2018-06-22 anticipated 106 Complete https://irct.ir/trial/31916 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to randomized groups based on the demographic data and then divided into two groups. The paired numbers are then assigned to the misoprostol group and the individual numbers to the misoprostol group together with nitroglycerin. Then by moving one of the numbers, we move in a predetermined direction. 2-3 Ripening cervix. Intervention 1: First intervention group: In the dual drug group, misoprostol is given at a dose of 25 micro grams vaginal with nitroglycerin 40 mg vaginal and after 6 hours, the cervix is examined for Bishop Score, and in the case of inappropriate cervix, 25 micrograms of the next misoprostol is administered up to a maximum of 4 doses. Intervention 2: Second intervention group: In the single dose group, misoprostol is given with a dose of 25 micrograms of vaginal and after 6 hours, the cervix is examined for Bishop Score in case of inappropriate cervix, 25 micro grams of misoprostol is administered up to a maximum of 4 doses. Yes - There is a plan to make this available What will be shared: Information is the most commonly used questionnaire, which is a statistical analysis When: Starting 6 months after publication To whom: Only available for people working in academic institutions Conditions: Path analysis Where to obtain: Dr Ezzatsadat Hajseyyedjavadi How to obtain: The email will be submitted to the project promoter at the discretion of the information. Comments:
public Maryam Rafiee
Bahonar Blvd, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 1317634156 +98 28 3333 6001 dr_seidjavadi@yahoo.com Qazvin University of Medical Sciences scientific Ezzatsadat Hajseyedjavadi
Bahonar Blvd, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 1317634156 +98 28 3333 6001 dr_seidjavadi@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Primigravida Gestational age>=37 week Bishop score<=4 Cephalic presentation Reactive NST Viable fetus Estimated weight before 4 kilogram Amniotic fluid >5 Singleton no limit no limit Female Surgery on the uteus or previous cesarean section chronic hypertension and preeclampsia uterine contractions The presence of heart, kidney and liver disease rapture of membrane IUGR Suspected embryonic anomalies chorioamnionitis Fever above 38 ° C polyhydramnios Pre-delivery hemorrhage fetal distress - Treatment - Drugs Treatment - Drugs First intervention group: In the dual drug group, misoprostol is given at a dose of 25 micro grams vaginal with nitroglycerin 40 mg vaginal and after 6 hours, the cervix is examined for Bishop Score, and in the case of inappropriate cervix, 25 micrograms of the next misoprostol is administered up to a maximum of 4 doses. Second intervention group: In the single dose group, misoprostol is given with a dose of 25 micrograms of vaginal and after 6 hours, the cervix is examined for Bishop Score in case of inappropriate cervix, 25 micro grams of misoprostol is administered up to a maximum of 4 doses. The duration of cervical ripening until delivery. Timepoint: 6 and 12 hours. Method of measurement: Vaginal exam. Duration of taking the drug until the onset of the active phase of labor. Timepoint: every 2 hours. Method of measurement: Vaginal exam. Duration of taking drug until delivery. Timepoint: every 2 hours. Method of measurement: Vaginal exam. Duration of the fist phase of labor. Timepoint: every 2 hours. Method of measurement: Vaginal exam. Duration of the second phase of labor. Timepoint: every 1 hours. Method of measurement: Vaginal exam. Reach to vaginal delivery. Timepoint: After delivery. Method of measurement: Date sheet. Type of delivery. Timepoint: After delivery. Method of measurement: Date sheet. Qazvin University of Medical Sciences Approved 2018-05-16 Ethics committee of Qazvin University of Medical Sciences Bahonar Blvd, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)