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IRCT20220507054766N1 IRCT 2022-08-08 Qazvin University of Medical Sciences A Comparison of the Effect of two Suture Materials on Isthmocele Formation after Cesarean section A Comparison of the Effect of two Suture Materials on Isthmocele Formation after Cesarean section 2022-05-08 anticipated 150 Complete https://irct.ir/trial/63380 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be divided into two groups by balanced blocked randomization. Blocking and sequencing of samples will be done with random allocation software (Random Allocation Software 1.0) and will include 25 blocks of 6. In order to conceal the random allocation process, the names of the groups were placed in envelopes, numbered from 1 to 150 on these envelopes and arranged in a box, the contents of the envelopes indicated the study groups. And after ensuring that the sample enters the research and obtaining written consent, the first envelope is taken in order of number and according to the content of the envelope, they are placed in one of the study groups, Blinding description: The sonologist does not know the type of suture used to close the uterine incision. N/A A comparison of the effect of two suture materials on isthmocele formation after cesarean. Intervention 1: Use of chrome thread to repair hysterotomy in cesarean section/ Chromic CAT GUT surgical sutures of Kayhan Teb Company are taken from cleaned connective tissue (collagen) and are prepared from sheep intestines. These yarns are packed in a solution of 90% alcohol, 2% glycerin and 8% distilled water. Chromic CAT GUT suture is impregnated with a solution of chromic salts. Intervention 2: Use of vicryl suture to repair hysterotomy in cesarean section /PGA is a sterile absorbable synthetic suture (vicryl) suture from Tamin Salamat Company, which is composed of polyglycolic acid polymer. The multi-strand woven yarn is coated with a mixture of calcium stearate and polycaprolactone to reduce yarn friction with the fabric. PGA suture is available in purple and colorless form (white). PGA suture meets the requirements of European and American pharmacopoeia. Yes - There is a plan to make this available What will be shared: All data of this research will be available When: Six months after the results were published To whom: It will be accessible to everyone Conditions: - Where to obtain: website How to obtain: - Comments:
public Samane nasiri
No. 33, Kamil Erfan St
Qazvin Iran (Islamic Republic of) 3471956654 +98 28 3378 6861 snasiri550@gmail.com Qazvin University of Medical Sciences scientific Farideh Movahed
Valiasr Street
Qazvin Iran (Islamic Republic of) 3415613176 +98 28 3324 2661 drmovahed@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Single tone pregnancy Gestational age over 38 weeks First cesarean section 18 years no limit Female History of uterine surgery such as myomectomy Cesarean section in the active phase of labor (dilation above 4 cm) Diabetes Chronic blood pressure Preeclampsia Anemia (Hb <10/5) Treatment - Devices Treatment - Devices Use of chrome thread to repair hysterotomy in cesarean section/ Chromic CAT GUT surgical sutures of Kayhan Teb Company are taken from cleaned connective tissue (collagen) and are prepared from sheep intestines. These yarns are packed in a solution of 90% alcohol, 2% glycerin and 8% distilled water. Chromic CAT GUT suture is impregnated with a solution of chromic salts. Use of vicryl suture to repair hysterotomy in cesarean section /PGA is a sterile absorbable synthetic suture (vicryl) suture from Tamin Salamat Company, which is composed of polyglycolic acid polymer. The multi-strand woven yarn is coated with a mixture of calcium stearate and polycaprolactone to reduce yarn friction with the fabric. PGA suture is available in purple and colorless form (white). PGA suture meets the requirements of European and American pharmacopoeia. Isthmocell formation. Timepoint: Examination of isthmocell formation 3 months after cesarean section. Method of measurement: Using ultrasound. Duration of operation,. Timepoint: Time recorded in the file. Method of measurement: Based on the information in the patient file. Amount of bleeding during surgery. Timepoint: 6 hours after surgery. Method of measurement: Primary hemoglobin minus hemoglobin 6 hours after surgery. Spotting. Timepoint: 3 months after surgery. Method of measurement: Question from the patient. Qazvin University of Medical Sciences Approved 2022-04-30 Ethics Committee of Qazvin University of Medical Sciences No 33, 7 Erfan, komil ave qazvin Qazvin Iran (Islamic Republic of)