]>
IRCT20130626013777N3 IRCT 2022-07-08 Vice chancellor for Research,Tabriz University Of Medical Sciences Comparison of the effect of intrauterine misoprostol administration with sublingual in second trimester abortions induction Comparison of the effect of intrauterine misoprostol administration with sublingual in second trimester abortions induction 2022-07-01 anticipated 86 Complete https://irct.ir/trial/64362 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not 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 1 and odd numbers extracted from the table are allocated to intervention group 2, Blinding description: Patient numbers will be randomly distributed in two groups, in a ratio of 1: 1 and will be kept inside a sealed envelope.The assistant of the researcher who is not in contact with the patients and will only be responsible for keeping the envelopes will announce how to induce the abortion after the call of the researcher based on the number assigned to the patient. 2 Therapeutic Abortion. Intervention 1: The first group includes intrauterine administration of misoprostol. A catheter under direct vision and under sterile conditions using chlorhexidine or betadine by using the vaginal speculum will be entered the uterine space through the endocervix and its balloon will be dilated with 30 cc of sterile saline or sterile distilled water. The infusion set will be connected to a Foley catheter and a 50 cc solution containing 500 micrograms of misoprostol (manufactured by Abu Reihan-Iran Pharmaceutical Company), 2 tablets of 200 micrograms, a tablet of 100 micrograms will be Dissolved in saline under sterile conditions at a rate of 20 drops per minute equivalent to 1 micrograms will be constantly infused and this infusion will be continued until the fetus is expelled or the catheter is expelled. Intervention 2: Intervention group 2: In the second group, misoprostol 400 microgram tablets (manufactured by Abu Reihan-Iran Pharmaceutical Company) are administered sublingually every 4 hours with control of vital signs. 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 analyzing the data, a decision will be made
public Shamsi Abbasalizadeh
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1553 9161 shamciabbasalizadeh@gmail.com Tabriz University of Medical Sciences scientific Shamsi Abbasalizadeh
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1553 9161 shamciabbasalizadeh@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 16 years Gestational age 14 to 22 weeks based on first trimester ultrasound Consent to participate in the study Having an indication for termination of pregnancy 16 years no limit Female Coagulation disorders or taking anticoagulant Possibility of ectopic pregnancy Probability of molar pregnancy Women with an IUD Women with a history of one or more cesarean sections or a history of uterine incision or myoctomy Pregnancy of placenta peria ‍‍ Parity 5 times or more O04 Therapeutic/Medical Abortion (termination of pregnancy) Treatment - Drugs Treatment - Drugs The first group includes intrauterine administration of misoprostol. A catheter under direct vision and under sterile conditions using chlorhexidine or betadine by using the vaginal speculum will be entered the uterine space through the endocervix and its balloon will be dilated with 30 cc of sterile saline or sterile distilled water. The infusion set will be connected to a Foley catheter and a 50 cc solution containing 500 micrograms of misoprostol (manufactured by Abu Reihan-Iran Pharmaceutical Company), 2 tablets of 200 micrograms, a tablet of 100 micrograms will be Dissolved in saline under sterile conditions at a rate of 20 drops per minute equivalent to 1 micrograms will be constantly infused and this infusion will be continued until the fetus is expelled or the catheter is expelled. Intervention group 2: In the second group, misoprostol 400 microgram tablets (manufactured by Abu Reihan-Iran Pharmaceutical Company) are administered sublingually every 4 hours with control of vital signs. The time interval between induction of abortion and excretion of pregnancy products. Timepoint: From the beginning of the intervention until the complete rejection of the fetus. Method of measurement: Clinical examination and ultrasound. Fever. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Thermometer. Nausea. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Vomiting. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Chills. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Chills. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Headache. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Skin rash. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Dizziness. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Dfficulty breathing. Timepoint: Every 4 hours from the beginning of the intervention until the complete abortion of the fetus. Method of measurement: Clinical examination. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2022-05-11 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number2, Golgasht Street تبریز East Azarbaijan Iran (Islamic Republic of)