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IRCT20180922041083N1 IRCT 2018-12-27 Babol University of Medical Sciences Effect of Isosorbide with Misoprostol on the cervical ripening Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on the cervical ripening in post-term pregnancy 2017-09-23 anticipated 150 Complete https://irct.ir/trial/34923 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using the randomization.com website. The size of blocks will be 8, Blinding description: The Isosorbide and placebo tablets, which are very similar in appearance, are located in two containers A and B. The resident of obstetrics that aware of the allocation will be given to patients (not aware) based on a randomized block size number. Staff is aware of the drug doses of both containers. The resident will transfer the data checklist to the outcome assessor that is not aware of allocation. 2-3 Vaginal Delivery. Intervention 1: In the Intervention group, Isosorbide tablets (Isocor Tablet, 40 m, Aria Pharmacy) are used vaginally. Then 24 hours later, after re-establishing a bishop: 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) is placed in the posterior fornix of the vagina. Intervention 2: In the control group, the placebo is placed by the senior resident of gynecology in the posterior fornix of the vagina, and 24 hours later, after re-establishing a bishop, 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) are placed in the posterior fornix of the vagina. Yes - There is a plan to make this available What will be shared: Primary outcome and some secondary outcomes are available to be shared. When: sharting 6 months after publication To whom: available for people working in academic institutions and can also apply to receive it. Conditions: Use in systematic review and meta-analysis studies is permitted Where to obtain: The data mentioned by the request will be available through my academic email.sh.barat@mubabol.ac.ir How to obtain: 6 months after the results are published, the data mentioned will be available by my email. Comments:

public Dr. Shahnaz Barat

Babol University of Medical Sciences, Ganj Afrouz Avenue

Babol Iran (Islamic Republic of) 4716681451 +98 11 3222 7667 shahnaz-barat200@yahoo.com Babol University of Medical Sciences scientific Dr. Mobina Baes

Babol University of Medical Sciences, Ganj Afrouz Avenue

Babol Iran (Islamic Republic of) 4716681451 +98 11 3222 7667 neda_amani60@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers from 18 to 40 years old Bishop Score 6 and less with a range score of 0 to 13 Body mass in the first trimester of pregnancy in the normal range (26 - 19.8 kg . m2) 41 weeks pregnancy based on ultrasonography of the first trimester of pregnancy Singleton and cephalic pregnancy Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study 18 years 40 years Female Pregnant women with a history of headache Misoprostol contraindications Alcohol consumption Preeclampsia and eclampsia Uncontrolled diabetes Intrauterine growth restriction Polyhydramnios and oligohydramnios Placenta previa or any other factor that prevents the induction of labor Interaction medicine with Isosorbide O80.0 Spontaneous Vertex Delivery Treatment - Drugs Placebo In the Intervention group, Isosorbide tablets (Isocor Tablet, 40 m, Aria Pharmacy) are used vaginally. Then 24 hours later, after re-establishing a bishop: 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) is placed in the posterior fornix of the vagina. In the control group, the placebo is placed by the senior resident of gynecology in the posterior fornix of the vagina, and 24 hours later, after re-establishing a bishop, 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) are placed in the posterior fornix of the vagina. The time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours). Timepoint: the time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours). Method of measurement: ٍVaginal examinatin by Hours. The time interval between administration of the first dose of Isosorbide until delivery of the neonate. Timepoint: ّFrom administration of the first dose of Isosorbide until delivery of the neonate. Method of measurement: Hours. The effect of Isosorbide on the Bishop score 24 hours after administration of Isosorbide. Timepoint: 24 hours after administration of Isosorbide To delivery. Method of measurement: Bishop Score Scale. The effect of Isosorbide on the number of Misoprostol used during labor. Timepoint: 24 hours after intervention to delivery. Method of measurement: Number Of misoprostol suppository. Babol University of Medical Sciences Approved 2018-08-20 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrouz Avenue Babol Mazandaran Iran (Islamic Republic of)