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IRCT20230612058462N1 IRCT 2023-10-09 Ahvaz University of Medical Sciences The effect of vaginal magnesium sulfate in preparing the cervix before labor induction Investigating the effect of vaginal magnesium sulfate in preparing the cervix before labor induction 2023-08-20 anticipated 104 Complete https://irct.ir/trial/70792 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups of 52 people, A and B, using random assignment computer software, and the number of groups and samples are recorded in this software, and people are randomly assigned to two groups. The randomization list will be determined by the statistician, Blinding description: The study will be conducted in a triple-blind manner. Completely similar vials containing normal saline (placebo or placebo) and magnesium sulfate will be used without drug labels. These vials will be labeled with an A or B code by another research colleague. They will be separated from each other and the patient and the examiner and the researcher and the analyst will be completely unaware of its nature. 3 The effect of vaginal magnesium sulfate in preparing the cervix before induction of labor. Intervention 1: Intervention group: Completely similar vials containing normal saline ( placebo) and 50% magnesium sulfate from Shahid Ghazi Pharmaceutical Company of Tabriz, which are without drug labels, will be used. These vials will be labeled with an A or B code by another research colleague They will be separated, and the patient and the examiner, the researcher and the analyst will be completely unaware of its nature. In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5 cc of vial A or B will be placed in the patient's cervix. 3 hours later, the patient will be examined again and the secondary Bishop score will be determined. Also, by entering the relevant code in the partograph form, the duration of labor and the active phase of labor were measured in each patient. Intervention 2: Control group: : Completely similar vials containing normal saline (placebo) and 50% magnesium sulfate from Shahid Ghazi Pharmaceutical Company of Tabriz, which are without drug labels, will be used. These vials will be labeled with an A or B code by another research colleague They will be separated, and the patient and the examiner, the researcher and the analyst will be completely unaware of its nature. In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5 cc of vial A or B will be placed in the patient's cervix. 3 hours later, the patient will be examined again and the secondary Bishop score will be determined. Also, by entering the relevant code in the partograph form, the duration of labor and the active phase of labor were measured in each patient. Yes - There is a plan to make this available What will be shared: Data related to the main outcome of the study When: 1 year after the publication of the article To whom: Medical students and gynecologists Conditions: Request through personal email - use for academic research Where to obtain: The applicant should send an email to the research unit of the university, after explaining the working method, the necessary information will be sent How to obtain: Email your request to the research unit of the university and give a brief explanation about your work method or the details required from this study so that the details will be sent via email. Comments:
public Seyede ayeh musavi
NO. 131 ،East Torbat Ave، saadi Qii
Ahwaz Iran (Islamic Republic of) ۶۱۳۶۶۸۵۴۷۷ +98 61 3337 4753 S.r.musavi88@gmail.com Ahvaz University of Medical Sciences scientific Seyede ayeh musavi
NO. 131 ،East Torbat Ave، saadi Qii
Ahwaz Iran (Islamic Republic of) ۶۱۳۶۶۸۵۴۷۷ +98 61 3337 4753 S.r.musavi88@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnant women 18_35 years BMI :19/8 _30 Gestational age 34_42 week by first trimester sonograghy A single alive fetus with cephalic presentation and 2500_4000 gr by sonograghy Having a Indication to labor induction 18 years 35 years Female Having indications for cesarean section Lack of consent to participate in the study Having a history of cesarean section Treatment - Drugs Placebo Intervention group: Completely similar vials containing normal saline ( placebo) and 50% magnesium sulfate from Shahid Ghazi Pharmaceutical Company of Tabriz, which are without drug labels, will be used. These vials will be labeled with an A or B code by another research colleague They will be separated, and the patient and the examiner, the researcher and the analyst will be completely unaware of its nature. In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5 cc of vial A or B will be placed in the patient's cervix. 3 hours later, the patient will be examined again and the secondary Bishop score will be determined. Also, by entering the relevant code in the partograph form, the duration of labor and the active phase of labor were measured in each patient. Control group: : Completely similar vials containing normal saline (placebo) and 50% magnesium sulfate from Shahid Ghazi Pharmaceutical Company of Tabriz, which are without drug labels, will be used. These vials will be labeled with an A or B code by another research colleague They will be separated, and the patient and the examiner, the researcher and the analyst will be completely unaware of its nature. In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5 cc of vial A or B will be placed in the patient's cervix. 3 hours later, the patient will be examined again and the secondary Bishop score will be determined. Also, by entering the relevant code in the partograph form, the duration of labor and the active phase of labor were measured in each patient. Bishop score. Timepoint: Before intervention and after 3 hours. Method of measurement: According to Bishop score. Total time of vaginal delivery. Timepoint: Since start labor induction till vaginal delivery. Method of measurement: Clock. Time of active phase of labor. Timepoint: Since cervix dilatation 4cm till vaginal delivery. Method of measurement: Clock. Type of delivery. Timepoint: After delivery. Method of measurement: View and Record file. Ahvaz University of Medical Sciences Approved 2023-08-25 Ethic committee of Ahvaz University of medical science Ahvaz - Golestan - Koi Saadi - East Torbat Street - Plate 131 Ahwaz Khouzestan Iran (Islamic Republic of)