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IRCT20200702047985N1 IRCT 2020-07-16 Gorgan University of Medical Sciences the effect of misoprostol in successful Induction of medical abortion the effect of misoprostol with and without letrozole in successful Induction of medical abortion and its relation with BHCG titrage and cervical length 2020-07-09 anticipated 120 Complete https://irct.ir/trial/49390 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after obtaining informed consent from patients, participants will be randomized using Block Randomization method into two groups, including group A (recipients of misoprostol with letrozole) and group B (recipients of misoprostol with placebo). In this way, all possible quadruple blocks (120 blocks) that include two groups are written, and each number is assigned to one of the blocks of the table and thus represents its particular state. Randomly, based on the table of random numbers obtained by the computer program, a block will be selected, then based on that, the samples will enter into the different groups of the study. This work will be continued until we reach a sufficient number of samples in each group (4 blocks will be selected by 42 times applying the permutation method.) For example, if block 1 will be selected in the first selection, this means that the first two samples should enter group A, and the third and fourth samples should enter group B. Likewise, the block will be selected again for the next 4 samples. Also during the randomization, matching between the two groups should be applied in terms of age, maternal parity, type of delivery, history of previous miscarriage, fetal anomaly and fetal death (Fetal Death) and the above cases should be included in both groups, Blinding description: Medications will be given to patients in a similar form and package by a clinical caregiver, and the researcher will only evaluate patients and evaluate the consequences. 2-3 medical Abortion. Intervention 1: Intervention group: Receptors of misoprostol and letrozole/). group A members will receive up to 10 mg letrozole (2.5 mg letrax tablets, made by Abu Reihan Pharmaceuticals [Iran]) on days 1 to 3. then on the morning of the third day of the study and will receive 800 micrograms of misoprostol (200 microgram misoglandin tablets, made by Samisaz Pharmaceuticals of Iran), including four 200 microgram tablets, vaginally. Intervention 2: Control group: recipients of misoprostol and placebo/Group B members will also receive placebo tablets, similar in appearance and taste to letrozole tablets produced by the Isfahan School of Pharmacy, on days 1 to 3 .then on the morning of the third day of the study and will receive 800 micrograms of misoprostol (200 microgram misoglandin tablets, made by Samisaz Pharmaceuticals of Iran), including four 200 microgram tablets, vaginally. Yes - There is a plan to make this available What will be shared: • Information obtained from patients will be confidential and only accessible by the investigators and after the study is completed, only part of it will cover the main implications. When: Data access period begins 3 months after the results are published To whom: Researchers working in academic institutions Conditions: Any statistical analysis on the data is possible. Where to obtain: Dr. Samaneh Mohammad Reza Khani, Email Address: mrkhn13662gmail.com phone number: 09129487710 How to obtain: If the applicant states the purpose of receiving the data and submits a proposal file related to the subject of his / her present study in a copy to the project executor, the file will be received after two weeks. Comments:
public Dr Moghadase Jahanshahi
Women's Clinic and Obstetrics and Gynecology Department, 2nd floor, Shahid Sayad Shirazi Hospital, Sayad Shirazi Blvd., Bahonar Square, Gorgan, Iran
gorgan Iran (Islamic Republic of) 4915663158 +98 17 3226 1150 Mogh.jahanshahi@gmail.com Gorgan University of Medical Sciences scientific Samaneh Mohammadreza khani
No. 4, Sarkhajeh Street 7 َAve, Sarkhajeh Blvd, Gorgan Town
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3220 3150 mrkhn1366@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Pregnant women candidates for termination of pregnancy under 18 weeks of gestation Missed abortions Legal and medical abortions Single pregnancy Hemoglobin level> 10 g/ l There should be no history or evidence of adrenal pathology, malignancies, porphyria, thromboembolism, severe or recurrent liver disease, or gestational pruritus Being consent to participate in the study 18 years no limit Female Any sensitivity to misoprostol and letrozole Having an intrauterine device Having a history of more than 2 cesarean sections Any abnormalities in pre-treatment blood tests, including CBC, liver and abnormalities in kidney function tests, including blood urea, creatinine, albumin, globulin, liver enzymes, and electrolytes Specific medical conditions such as severe anemia, coagulation disorders, active liver disease, cardiovascular disease, glaucoma, and uncontrolled seizure disorders Having a history of thromboembolism, adrenal diseases, steroid-dependent cancer, porphyria, and disorders that require treatment with glucocorticoids, such as bronchial asthma O02.1 Missed abortion Treatment - Drugs Treatment - Drugs Intervention group: Receptors of misoprostol and letrozole/). group A members will receive up to 10 mg letrozole (2.5 mg letrax tablets, made by Abu Reihan Pharmaceuticals [Iran]) on days 1 to 3. then on the morning of the third day of the study and will receive 800 micrograms of misoprostol (200 microgram misoglandin tablets, made by Samisaz Pharmaceuticals of Iran), including four 200 microgram tablets, vaginally Control group: recipients of misoprostol and placebo/Group B members will also receive placebo tablets, similar in appearance and taste to letrozole tablets produced by the Isfahan School of Pharmacy, on days 1 to 3 .then on the morning of the third day of the study and will receive 800 micrograms of misoprostol (200 microgram misoglandin tablets, made by Samisaz Pharmaceuticals of Iran), including four 200 microgram tablets, vaginally Percentage of induction of successful fetal abortion with transvaginal ultrasound. Timepoint: group A members will receive up to 10 mg letrozole (2.5 mg letrax tablets, made by Abu Reihan Pharmaceuticals [Iran]) on days 1 to 3. Group B members will also receive placebo tablets, similar in appearance and taste to letrozole tablets , on days 1 to 3 .finally all patients will undergo transvaginal ultrasound on the fifth day after medical therapy. Method of measurement: Transvaginal ultrasound for successful abortion and BHCG check. Side Effects of Misoprostol. Timepoint: During the study, blood pressure, heart rate and patient temperature will be checked every four hours by the ward nurse and side effects including fever (body temperature more than 38 degrees of Celsius), sweating, hot flashes, arthralgia and fatigue, nausea, vomiting, bone pain, dizziness, muscle aches, diarrhea, abdominal pain, stomach pain, vaginal bleeding, sore throat, pain when urinating, difficulty in urinating, cough, rash, flu-like symptoms, difficulty in sleeping or in staying asleep, amount of bleeding, and the time of discarding of the residual tissue will be recorded by the resident and these data will be written in the patient's dossier. Method of measurement: Measuring fever with a thermometer and measuring blood pressure with a cuff pressure gauge, clinical examinations and a history of the patient. Gorgan University of Medical Sciences Approved 2020-06-27 Ethics Committee of Golestan University of Medical Science Ethics Committee of the Vice Chancellor for Research and Technology, 3rd Floor, School of Dentistry, Golestan University of Medical Sciences, Shast Kola Road, Gorgan, Iran Gorgan Golestan Iran (Islamic Republic of)