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IRCT20180409039247N9 IRCT 2024-01-04 Tehran University of Medical Sciences Combined effect of dexamethasone, hyoscine and misoprostol drugs during therapeutic or legal abortion in patients visiting Imam Khomeini Hospital in Tehran Combined effect of dexamethasone, hyoscine and misoprostol drugs during therapeutic or legal abortion in patients visiting Imam Khomeini Hospital in Tehran 2024-02-20 anticipated 75 Complete https://irct.ir/trial/73972 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are assigned to three study groups (A: misoprostol, B: misoprostol + dexamethasone, and C: misoprostol + hyoscine) using a random allocation table and block classification.The randomization list will be administered using identical, sequentially numbered study drug containers, and these containers will be identically labeled by two investigators who will not be involved in the recruitment of study subjects. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 3 alleles of size 6. N/A Abortion. Intervention 1: Intervention group: Vaginal misoprostol 400 micro every 4 hours until abortion. Intervention 2: Intervention group: Vaginal misoprostol 400 micrograms every 4 hours + dexamethasone 8 mg intravenous injection (with the first dose of misoprostol). Intervention 3: Intervention group: Vaginal misoprostol 400 micrograms every 4 hours + one dose of hyosin 20 mg intravenous injection (with the first dose of misoprostol). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Marjan Ghaemibidgoli
Emam khomeini hospital
Tehran Iran (Islamic Republic of) 14146 +98 21 8800 4858 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences scientific Marjan Ghaemibidgoli
Emam khomeini hospital
Tehran Iran (Islamic Republic of) 14146 +98 21 8800 4858 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) pregnant woman aged 25-45 who has become pregnant spontaneously and the necessity of performing a therapeutic or legal abortion has been definitively diagnosed. Patient's awareness and acceptance of two medical and surgical methods and complications resulting from each of them Intrauterine pregnancy with a gestational age of 14 weeks or less based on ultrasound or the date of the last menstrual period a reason to terminate the pregnancy (missed abortion, blighted ovum, therapeutic abortion) 25 years 45 years Female Allergy to Drug IUD (intrauterine device) severe anemia coagulation disorder or use of anticoagulants uncontrolled seizures adrenal disease with high blood pressure cardiovascular disease active liver disease use Steroid drugs O02.1 Missed abortion Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Vaginal misoprostol 400 micro every 4 hours until abortion Intervention group: Vaginal misoprostol 400 micrograms every 4 hours + dexamethasone 8 mg intravenous injection (with the first dose of misoprostol) Intervention group: Vaginal misoprostol 400 micrograms every 4 hours + one dose of hyosin 20 mg intravenous injection (with the first dose of misoprostol) Comparison of intervention in the amount of patient pain during abortion, comparison of intervention in the amount of patient bleeding during abortion, comparison of intervention in the time required for abortion. Timepoint: The amount of bleeding and the time required are measured at the end of the process. Method of measurement: The amount of bleeding is measured based on the patient's pads and the time is measured based on hours and minutes. Tehran University of Medical Sciences Approved 2023-10-10 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences East Bagherkhan Street Tehran Tehran Iran (Islamic Republic of)