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IRCT20190730044380N1 IRCT 2019-11-11 Esfahan University of Medical Sciences Evaluation of the effect of misoprostol with and without letrozol in missed aborted Evaluation of the effect of misoprostol with and without letrozole as premedication on induction of abortion in pregnant women with missed abortion at their first trimester of pregnancy 2016-08-22 anticipated 126 Complete https://irct.ir/trial/43152 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Random sequence generation Used random allocation software Allocation concealment ;Sequentially numbered, sealed, opaque envelopes, Blinding description: Double -blinded Participants and researcher and outcome assessor who was same as the researcher were blinded. Participants were divided into two random groups after informed consent, and then the drug was administered without knowing the nature of the drug being prescribed. To blind the researcher, the researcher was not present at the beginning and at the time of administration of the drug and was prescribed by a clinical caregiver and a clinical caregiver was present. 3 Missed abortion. Intervention 1: Intervention group: missed aborted women with geatational age less than 12 weeks- The case group received 10 mg of letrozole daily for three days, then received 800 μg of vaginal misoprostol, and finally received the same dose of misoprostol after four hours. Intervention 2: Control group: missed aborted women with geatational age less than 12 weeks-The CONTROL group calcium carbonate tablet daily for three days, then received 800 μg of vaginal misoprostol, and finally received the same dose of misoprostol after four hours. Yes - There is a plan to make this available What will be shared: information of main consequence can be shared When: 1 YEAR after publish of the result To whom: academic researcher Conditions: in clinical research Where to obtain: mrym.gn72@gmail.com How to obtain: about 1 mounth Comments:
public Maryam Goharian
Soffeh blvd,alzahra hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mrym.gn72@gmail.com Esfahan University of Medical Sciences scientific Maryam Goharian
Soffeh,Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 MRYM.GN72@GMAIL.COM Esfahan University of Medical Sciences Iran (Islamic Republic of) 1:Gestational age less than 12 week(confirmed with ultrasonogarphy) patient with missed abortion (confirmed with ultrasonography) acceptance of participant patient age above 18 years old hemoglobin above 12 18 years no limit Female Clinical manifestation or history of adrenal gland impairment History of any malignancy History or clinical evidence of any thromboembolic impairment History of hepatic or renal diseases Have IUD History of cardiovascular disease that prescription of misoprostol or letrozol forbidden based on cardiologist opinion. History of use corticosteroid Present of classic scar or t shape scar on the uterus Impairment of coagulation test O02.1 Missed abortion Treatment - Drugs Placebo Intervention group: missed aborted women with geatational age less than 12 weeks- The case group received 10 mg of letrozole daily for three days, then received 800 μg of vaginal misoprostol, and finally received the same dose of misoprostol after four hours Control group: missed aborted women with geatational age less than 12 weeks-The CONTROL group calcium carbonate tablet daily for three days, then received 800 μg of vaginal misoprostol, and finally received the same dose of misoprostol after four hours PRESENT OF ABORTION:COMPLETE,in complete. Timepoint: every 12 hours. Method of measurement: ultrasonography. Time interval from induction to abortion. Timepoint: hours. Method of measurement: questionaire. Esfahan University of Medical Sciences Approved 2017-08-23 Ethics committee of isfahan University of Medical Sciences SOFFEH blvd,alzahra hospital ISFAHAN Isfehan Iran (Islamic Republic of)