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IRCT20200603047648N1 IRCT 2020-07-13 Karaj University of Medical Sciences Mesoprostol and Dilapen in the preparation of the cervix for abortion Comparison of the effect of Misoprostol and Diplen with Misoprostol in cervical priming in the first and second trimesters 2020-09-22 anticipated 196 Complete https://irct.ir/trial/48736 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random allocation of individuals to two groups of intervention and current treatment was performed using Balanced bloch randomization technique. Using R software to generate random number chains 1 to 6 (the number of possible states for placement in blocks) Until the volume of the sample was reached. Preparation of random allocation sequences of individuals and placing them in sealed envelopes (sealed) and numbered with a 5-digit serial number by the third person who plays a role in designing the study. Has not, has been done, Blinding description: In the treatment group, in addition to receiving vaginal diazepam mesoprostol, it is vaginally placed by a specialist doctor, and in the control group, only mesoprostol is received. After the procedure, patients will be examined by 2 blind researchers who do not know to whom dilapen is placed. Who has only used misoprostol. Patients will be examined by two researchers in terms of postoperative complications. The patient will then be hospitalized for side effects after surgery and the consequences of the procedure. The patient's opinion is checked by a student (specific to this task) that the student does not know who received the diplopen and who did not receive it and records all the consequences. In fact, neither the researcher nor the evaluator of the consequences of how patients are divided. 3 Medical abortion in first and second trimester. Intervention 1: Control group: Control group: In the control group, to prepare the cervix, 400 micrograms of misoprostol will be placed vaginally by a gynecologist 4 hours before surgery. Mesoprostol is an analogue of prostaglandin E1, which is the best option for cervical preparation studies in terms of speed, function and cost. Intervention 2: Intervention group: Intervention group: In this group, to prepare the cervix, 24 hours before the surgery, a diplopene is placed vaginally by the obstetrician and gynecologist for the patient. The cervix becomes vaginal). 4 hours before surgery, 400 micrograms of misoprostol will be vaginally placed by a gynecologist (exactly as done for the control group). The synergistic effect of the two can be examined together. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Bita Badehnoosh
Kamali hospital ,Kamali Ave, shohada sq, Beheshti blvd
Karaj Iran (Islamic Republic of) 4156853445 +98 26 4158 6658 badehnoosh@abzums.ac.ir Karaj University of Medical Sciences scientific Bita Badehnoosh
Alborz university of medical sciences , Saffarian Alley , Golshahr
Karaj Iran (Islamic Republic of) 4156853445 0098 26 4158665 badehnoosh@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Age over 18 years for mothers Less or equal pregnancy age 24 weeks based on (LMP) and ultrasound of the first 3 months of pregnancy Patient satisfaction to participate in the study Legal permission for abortion is from the relevant authorities 18 years no limit Female Patients under 18 years of age Contraindications to the use of misoprostol (drug allergy, active asthma, heart disease, renal failure or glaucoma) Active genital infection Structural disorders of the uterus and bladder Cervical cancer History of cervical surgery O04.80 (Induced) termination of pregnancy with unspecified complications Treatment - Drugs Treatment - Devices Control group: Control group: In the control group, to prepare the cervix, 400 micrograms of misoprostol will be placed vaginally by a gynecologist 4 hours before surgery. Mesoprostol is an analogue of prostaglandin E1, which is the best option for cervical preparation studies in terms of speed, function and cost. Intervention group: Intervention group: In this group, to prepare the cervix, 24 hours before the surgery, a diplopene is placed vaginally by the obstetrician and gynecologist for the patient. The cervix becomes vaginal). 4 hours before surgery, 400 micrograms of misoprostol will be vaginally placed by a gynecologist (exactly as done for the control group). The synergistic effect of the two can be examined together Cervical dilatation rate. Timepoint: Before surgery and after general anesthesia. Method of measurement: Examination by a specialist. Feeling sick. Timepoint: Before surgery and after general anesthesia. Method of measurement: Examination by a specialist doctor based on a five-digit criterion (without discomfort, with discomfort, relatively uncomfortable, very uncomfortable, unbearable). Servicing preparation time. Timepoint: After receiving the drug until the start of surgery. Method of measurement: Examination by a specialist. Side effects( include vaginal pain, pressure on the bladder, diarrhea and vaginal bleeding, and incomplete miscarriage.). Timepoint: Before general anesthesia, after the procedure and the patient regained consciousness. Method of measurement: Examination by a specialist doctor, ultrasound (if you have symptoms in favor of incomplete abortion once before discharge). Cervical consistency. Timepoint: Before surgery and after general anesthesia. Method of measurement: Examination by a specialist doctor based on three-digit criteria (according to the surgeon, soft, medium, hard). Karaj University of Medical Sciences Approved 2020-05-26 Ethics committee of Alborz University Of medical Sciences Saffarian Alley, Golshahr Karaj Alborz Iran (Islamic Republic of)