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IRCT20190107042266N2 IRCT 2020-01-27 Semnan University of Medical Sciences Comparison of Extra-amniotic dexamethasone infusion with extra-amniotic salin infusion in cervical ripening for labor induction Comparison of Extra-amniotic dexamethasone infusion with extra-amniotic salin infusion in cervical ripening for labor induction 2020-01-20 anticipated 60 Complete https://irct.ir/trial/43805 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: They will randomly be divided into two groups. For randomization, four segmented randomized blocks (permutation) will be used. Will be have two treatment methods. In 4 segmented blocks, two participants will be devoted to intervention group and two participants will be devoted to control group. There will be six different modes for 4 segmented blocks (TTCC, TCTC, TCCT, CCTT, CTCT, CTTC). Designation list will be prepared based on the randomized numbers created by excel with the help of a consultant before initiating the work (between 0 and 1). Rrandomized numbers "0 to 0.16" from the mixture of “TTCC", randomized numbers "0.16 to 0.33" from the mixture of " TCTC", randomized numbers "0.33 to 0.5" from the mixture of “TCCT”, randomized numbers "0.5 to 0.66" from the mixture of "CCTT", randomized numbers "0.66 to 0.83” from the mixture of "CTCT” and randomized numbers “0.83 to 1" from the mixture of "CTTC" will be used, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses will be completed. Another person at the hospital, who is not involved in the trial and not aware of random sequences, will be assigned the participants into two groups. 3 Pregnant wemen. Intervention 1: Intervention group: Foley catheter (size 26) will be inserted into the cervix. The Foley catheter balloon will be filled with 30 ml of sterile water. 20 mg of dexamethasone will be mixed with sterile water to bring the volume to 20 ml. then the Solution will be infused with normal saline sterile infusion (at a rate of 1 ml/min) into the extra amniotic. Every hour after injection، They are examined for exiting catheter. After exiting catheter ، Bishop score will be determined again and labor induction will be implemented with oxytocin. Intervention 2: Foley catheter (size 26) is inserted into the cervix. The Foley catheter balloon will be filled with 30 ml of sterile water. 20 ml of distilled infused water and then the normal saline sterile infusion will be infused into the exterior amniotic. Every hour after injection، they will be examined for exiting catheter. After exiting catheter ، Bishop score will be determined again and labor induction will be implemented with oxytocin. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is not more information
public Dr Shahrzad Aghaamoo
Hospital Amiralmomenin, Mostafa Khomeini Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 aghaamoo_shahrzad@yahoo.com Semnan University of Medical Sciences scientific Dr Shahrzad Aghaamoo
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 aghaamoo_shahrzad@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Gestational age of 37-42 weeks Candidate for induction of labor Bishop score of less than 5 15 years 45 years Female Uterine anomalies Placenta previa or placental low lying Authentic History of vaginal bleeding in the second and third trimester of pregnancy Active genital herpes Intrauterine fetal death (IUFD) History of uterine classic incision Vasa Previa Pregnant s Z33 Treatment - Drugs Treatment - Drugs Intervention group: Foley catheter (size 26) will be inserted into the cervix. The Foley catheter balloon will be filled with 30 ml of sterile water. 20 mg of dexamethasone will be mixed with sterile water to bring the volume to 20 ml. then the Solution will be infused with normal saline sterile infusion (at a rate of 1 ml/min) into the extra amniotic. Every hour after injection، They are examined for exiting catheter. After exiting catheter ، Bishop score will be determined again and labor induction will be implemented with oxytocin. Foley catheter (size 26) is inserted into the cervix. The Foley catheter balloon will be filled with 30 ml of sterile water. 20 ml of distilled infused water and then the normal saline sterile infusion will be infused into the exterior amniotic. Every hour after injection، they will be examined for exiting catheter. After exiting catheter ، Bishop score will be determined again and labor induction will be implemented with oxytocin. Cervical ripening. Timepoint: The measurement of cervix at the beginning of the study and before initiation of the intervention (until 6 hours after initiation of the study) till the creation of bishop score of five and higher. Method of measurement: Vaginal exam based on Bishop score. Neonatal Apgar. Timepoint: First and fifth minutes after birth. Method of measurement: Standard method. Semnan University of Medical Sciences Approved 2019-09-16 Ethics Committee in Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd Semnan Semnan Iran (Islamic Republic of)