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IRCT20200127046280N2 IRCT 2020-10-17 Qazvin University of Medical Sciences The Comparative evaluation of effect of Sublingual Misoprostol versus cervical misoprostol on second Trimester abortions The comparative evaluation of the effect of sublingual misoprostol versus wet cervical misoprostol on duration of abortion in patients candidates for abortion in early second Trimester 2020-10-22 anticipated 200 Complete https://irct.ir/trial/45664 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are divided into two intervention groups using simple randomization method.The randomization method used in this study is the use of a table of random numbers.Random number table is a set of numbers that is generated without a specific pattern or order and they generated randomly and they are formed in a table.In first the direction of reading the numbers was specified.To read the numbers, random numbers are read from the left side of the table, then even numbers extracted from the table are allocated to intervention group a and odd numbers extracted from the table are allocated to intervention group b, Blinding description: Participants are unaware of treatment allocation and are divided into groups a and b. Group a receives sublingual misoprostol with cervical placebo and group b receives cervical misoprostol with sublingual placebo. Finally, the results of the work are filled by the midwife of the ward, using the questionnaire form and provided to the researcher. 2-3 Abortion. Intervention 1: First intervention group (group a): This group will receive 200 mcg of sublingual misoprostol from the brand (Cytotec, Searle, England) along with cervical placebo(alborz daroo company) and then the mentioned dose will be repeated every 4 hours until the abortion.The maximum duration of drug administration will be up to 48 hours. Intervention 2: Intervention group 2 (group b): This group will receive 200 mcg of cervical misoprostol from brand (Cytotec, Searle, England) moistened with a few drops of distilled water along with sublingual placebo(alborz daroo company) and then the mentioned dose is repeated every 4 hours until abortion. The maximum duration of drug administration will be up to 48 hours. Yes - There is a plan to make this available What will be shared: A part of the data, such as information about the main outcome, can be shared. When: Access period starts 6 months after publishing the results. To whom: It will be available only to researchers working in academic and scientific institutions Conditions: If another similar clinical trial is performed Where to obtain: Email How to obtain: After receiving the email and the proposal and ensuring that the information is not misused Comments:
public Masoumeh Dadashaliha
No. 2, Bahar Doctors Building ,East Bouali St.
Qazvin Iran (Islamic Republic of) 3491658875 +98 28 3322 9304 dadashaliham@yahoo.com Qazvin University of Medical Sciences scientific Masoumeh Dadashaliha
No. 2, Bahar Doctors Building ,East Bouali St.
Qazvin Iran (Islamic Republic of) 3491658875 +98 28 3322 9304 dadashaliham@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Unifetal pregnancy Missed abortion Fetal malformations Blighted ovum Trisomies Gestational age ( 12 weeks and less than 12 weeks ) 16 years 45 years Female Rupture of membrane History of cesarean section more than once History of allergy to misoprostol and prostaglandins Contraindications of prostaglandin use ( like heart disease, kidney disease, history of seizures and hypotension ) O02.1 Missed abortion Treatment - Drugs Treatment - Drugs First intervention group (group a): This group will receive 200 mcg of sublingual misoprostol from the brand (Cytotec, Searle, England) along with cervical placebo(alborz daroo company) and then the mentioned dose will be repeated every 4 hours until the abortion.The maximum duration of drug administration will be up to 48 hours. Intervention group 2 (group b): This group will receive 200 mcg of cervical misoprostol from brand (Cytotec, Searle, England) moistened with a few drops of distilled water along with sublingual placebo(alborz daroo company) and then the mentioned dose is repeated every 4 hours until abortion. The maximum duration of drug administration will be up to 48 hours. The time interval between induction of abortion and excretion of pregnancy products. Timepoint: After intervention and then every one hour. Method of measurement: clock. Nausea (drug side effects). Timepoint: After intervention and then every one hour. Method of measurement: Clinical examination and questioning of the patient. Vomiting (drug side effects). Timepoint: After intervention and then every one hour. Method of measurement: Clinical examination and questioning of the patient. Fever (drug side effects). Timepoint: After intervention and then every one hour. Method of measurement: Thermometer. Diarrhea (drug side effects). Timepoint: After intervention and then every one hour. Method of measurement: Clinical examination and questioning of the patient. Headache (drug side effects). Timepoint: After intervention and then every one hour. Method of measurement: Clinical examination and questioning of the patient. Abortion type (Complete or incomplete). Timepoint: After intervention and then every one hour. Method of measurement: Clinical examination with speculum and doing ultrasonography. Qazvin University of Medical Sciences Approved 2020-01-25 Ethics committee of Qazvin University Of Medical Science No 4, mavedat ave, shahid beheshti blvd Qazvin Qazvin Iran (Islamic Republic of)