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IRCT20200217046521N1 IRCT 2021-10-03 Dezfoul University of Medical Sciences Evaluation of the effects of misoprostol and letrozole in therapeutic abortion Comparison of the effect of misoprostol and letrozole in the first-trimester abortion of patients referring to Ganjavian Hospital in Dezful in 1400 2021-09-21 anticipated 75 Complete https://irct.ir/trial/52635 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the samples and also to balance the study groups, patients will be divided into 3 groups by the block randomization method by the researcher. In this method, the researcher will place each patient in one of 3 groups: A (misoprostol) or B (3-day letrozole + misoprostol) or C (5-day letrozole + misoprostol). Blocking in the form of six blocks One will be done and 8 blocks will be formed according to the number of sample population. We predict all possible arrangements of groups, for example, the first block will be AABBCC and the next block. For example, it will be predicted as CAB CAB and the rest of the blocks will be defined in the same way. Due to the large number of blocks, block randomization software will be used and then 8 blocks will be selected randomly with the help of a table of random numbers. Individuals will also be randomly selected and placed in blocks. Eventually, the sample size will be the same in the groups and 25 patients will be in each group A, B and C, Blinding description: Participants in the study will be placed in three ABC groups by the researcher. Patient randomization will be done by the researcher in blocks and after coding, the study and control groups will enter the data for analysis in the software The group treated with misoprostol with code A, the group treated with letrozole 3 days + misoprostol with code B and the group treated with letrozole 5 days + misoprostol with code C will be coded. It should be noted that the participants in the study do not know about the treatment and medication regimen performed for them, but researchers and statistical analysts know what diet each participant received. 3 medical abortion. Intervention 1: Control group: Group A patients in whom abortion will be performed with vaginal and oral misoprostol are given two 200 µg misoprostol tablets orally (sublingually) and two vaginally in the posterior vaginal fornix (800µ totally) and then this amount will be repeated every 4 hours p to 3 days as needed.Intervention group: In group B, where abortion is performed vaginally with oral letrozole and misoprostol, 10 mg of oral letrozole is given to the patient twice daily for 3 days (2 tablets of 2.5 mg each) followed by 400 mg. Misoprostol will be used vaginally in the posterior fornix and 4g400 misoprostol will be used sublingually. Intervention 2: Intervention group: In group B, abortion treatment with oral letrozole and misoprostol will be performed vaginally, 10 mg oral letrozole for 3 days for the patient in two meals a day (2 tablets of 2.5 mg each meal) is prescribed on an outpatient basis and then in On the last day of taking letrozole, 400 mg of misoprostol will be administered vaginally in the posterior fornix and 400 mg of misoprostol will be used sublingually. Intervention 3: Intervention group: In group B, abortion treatment with oral letrozole and misoprostol will be performed vaginally, 10 mg oral letrozole for 5 days for the patient in two meals a day (2 tablets of 2.5 mg each meal) is prescribed on an outpatient basis and then in On the last day of taking letrozole, 400 mg of misoprostol will be administered vaginally in the posterior fornix and 400 mg of misoprostol will be used sublingually. Yes - There is a plan to make this available What will be shared: All documents and statistical tests and the results will be mentioned in the form of graphs and tables in the final article When: Access period starts 6 months after the results are published To whom: By publishing the article, all people who have access to the Internet can access the results Conditions: In order to develop the science related to abortion treatment and facilitate the process with the least complications, everyone will be able to access Where to obtain: It will be available on Google Scholar by mentioning the names of the authors and keywords How to obtain: nothing Comments:
public vahid.kheirandish
No. 646, Shahid Dastgheib alley, Sahel street ,Shariati crossroads
Dezful Iran (Islamic Republic of) 6461865967 +98 71 4452 7941 vahid.kheirandish40@gmail.com Dezfoul University of Medical Sciences scientific dr. Sima janati
Department of Obstetrics and Gynecology, Ganjavian Hospital, Dezful-Andymeshk Road
Dezfull Iran (Islamic Republic of) 6461643981 +98 42429781 sjanati@ymail.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Hemoglobin level greater than 10 gr / l Diastolic pressure less than 95 mmhg Serum hcg level less than 3000 iu / l Gestational age less than 14 weeks 18 years no limit Female Use of abortion drugs in the last three months itching during pregnancy Existence of adrenal disorders Porphyria, steroid-related cancer, acute or chronic liver disease or thromboembolism History of chronic lung diseases such as asthma, bronchitis, bronchiectasis known allergy to letrozole or misoprostol Breast feeding Multipfetal pregnancy More than two previous cesarean sections uterine surgery and myomectomy contraindications to the letrozol and mosoprostol Existence of intrauterine devices (IUD) Uncontrolled seizures Coagulation disorder or use of anticoagulants Active liver disease, cardiovascular disease Adrenal disease Consumption of glucocorticoids 000-008 Medical abortion Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Group A patients in whom abortion will be performed with vaginal and oral misoprostol are given two 200 µg misoprostol tablets orally (sublingually) and two vaginally in the posterior vaginal fornix (800µ totally) and then this amount will be repeated every 4 hours p to 3 days as needed.Intervention group: In group B, where abortion is performed vaginally with oral letrozole and misoprostol, 10 mg of oral letrozole is given to the patient twice daily for 3 days (2 tablets of 2.5 mg each) followed by 400 mg. Misoprostol will be used vaginally in the posterior fornix and 4g400 misoprostol will be used sublingually. Intervention group: In group B, abortion treatment with oral letrozole and misoprostol will be performed vaginally, 10 mg oral letrozole for 3 days for the patient in two meals a day (2 tablets of 2.5 mg each meal) is prescribed on an outpatient basis and then in On the last day of taking letrozole, 400 mg of misoprostol will be administered vaginally in the posterior fornix and 400 mg of misoprostol will be used sublingually. Intervention group: In group B, abortion treatment with oral letrozole and misoprostol will be performed vaginally, 10 mg oral letrozole for 5 days for the patient in two meals a day (2 tablets of 2.5 mg each meal) is prescribed on an outpatient basis and then in On the last day of taking letrozole, 400 mg of misoprostol will be administered vaginally in the posterior fornix and 400 mg of misoprostol will be used sublingually. Fetus abortion. Timepoint: Before and after abortion. Method of measurement: Eight hours after the intervention, and every twenty-four hours up to three days if the abortion doesn't occur. Dezfoul University of Medical Sciences Approved 2020-10-31 Ethics Committees of Dezful University of Medical Sciences Azadegan Boulevard, Daneshjoo Square Dezful Khouzestan Iran (Islamic Republic of)