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IRCT20130626013777N2 IRCT 2019-02-14 معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز Comparison the effect of Letrozole with Misoprostol on induction of second trimester abortion in pregnancy The effect of letrozole with misoprostol on induced abortion in the second trimester 2019-02-13 anticipated 86 Complete https://irct.ir/trial/37257 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to two groups of 38 A (receiving Letrozole and Misoprostol) and B (Misoprostol) by using the random numbers table. 2 Termination of pregnancy in the second trimester. Intervention 1: Intervention group: 7.5 mg ، letrozole (Manufacturing Iran Hormones Company) prescribed up to three doses at home, the patient was hospitalized on the fourth and Misoprostol 400 micrograms (made by SEARLE UK) is administered sublingually every 3 hours to a maximum of 5 doses. Intervention 2: Control group: The group received placebo for 4 days (Folic acid as blind-made by IRAN DARO) and then misoprostol according to the ACOG protocol. 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 After the completion of the project, the decision will be made.
public Shamsi Abbasalizadeh
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Shamsi Abbasalizadeh
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) patients more than 18 years of age Gestational age of 13 to 26 with an indication for termination of pregnancy in medical method Hb above 10 Reason for termination of pregnancy, such as missed abortion; Pregnancy NULL; Therapeutic abortion legal authorization and consent of patients BMI between 25-25 18 years no limit Female Pain and bleeding Drug sensitivity to misoprostol; Severe anemia Coagulopathy or taking anticoagulants Active liver disease Cardiovascular disease and uncontrolled seizures Adrenal disease history of corticosteroid use O04 Medical abortion Treatment - Drugs Treatment - Drugs Intervention group: 7.5 mg ، letrozole (Manufacturing Iran Hormones Company) prescribed up to three doses at home, the patient was hospitalized on the fourth and Misoprostol 400 micrograms (made by SEARLE UK) is administered sublingually every 3 hours to a maximum of 5 doses. Control group: The group received placebo for 4 days (Folic acid as blind-made by IRAN DARO) and then misoprostol according to the ACOG protocol. Abortion. Timepoint: The start of the intervention up to 24. Method of measurement: Ultrasound. Time between medication abortion. Timepoint: The start of the intervention up to 24. Method of measurement: hour. The need for curettage. Timepoint: Seven days after abortion. Method of measurement: Clinical. Side effects. Timepoint: Intervention to 24 hours after administration. Method of measurement: Clinical. معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز Approved 2019-01-21 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)