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IRCT20181211041932N2 IRCT 2019-03-30 Hamedan University of Medical Sciences The study of comparsion effect of closure versus non-closure of the peritoneum on Maternal Short-Term Complications at elective and Emergency cesarean section The study of comparsion effect of closure versus non-closure of the peritoneum on Maternal Short-Term Complications at elective and Emergency cesarean section 2019-04-09 anticipated 84 Complete https://irct.ir/trial/38185 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using available sampling, patients are divided into two layers of elective cesarean section and emergency cesarean section. In each layer, a randomized simple method is used to select the peritoneal repair method for each patient, In this way, using the lottery, the first cesarean will be surgically treated with one of the two techniques of closure or non-closure of the peritoneum and the next patient with the opposite technique, This method continues to complete the number of samples of both groups in each of the layers, Blinding description: In this double blind study, participants and outcome evaluators are blinded to the division of subjects into study groups. To keep the participants blind: At the beginning of the study, we will explain the purpose of the study for them and we will describe two different methods of repairing the peritoneum. But the details of the method that used for each patient are not explained. To keep the outcome evaluators blind: The surgical procedure information is only recorded in the patient's surgical record and outcome evaluators dont have access to information. N/A caesarean section. Intervention 1: Control group: in control group the visceral and parietal peritoneum is closure. Intervention 2: Intervention group: in the intervention group visceral and parietal peritoneum non-closure. Yes - There is a plan to make this available What will be shared: All personal data is shared after unidentifiable people.Includes demographic data and data related to study variables. When: The data is shared three months after the publication of the results To whom: All researchers can take data. Conditions: The data is provided under the condition that First, they have a clear purpose for using the data. Secondly, the source of data should be mentioned wherever these data are to be used Where to obtain: can use the following e-mail address to receive the data. liondelzandii@gmail.com How to obtain: After sending the request to the e-mail address, the data will be sent in time. Comments:
public Mehrnosh Mostafayi
Hamedan University of Medical Science, Shahid Fahmideh Street, Hamedan City
Hamedan Iran (Islamic Republic of) 65178 +98 81 3525 0182 mehrnush_mostafayi@yahoo.com Hamedan University of Medical Sciences scientific Behzad Imani
Hamedan University of Medical Sciences, Shahid Fahmideh street, Hamedan City
Hamedan Iran (Islamic Republic of) 65178 +98 81 3838 1017 b.imani@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) The age range of mothers is 18-40 years old Not having chronic disease like diabetes Not having drug addiction 18 years 40 years Female Having previous laparotomy history Unwillingness to work with a researcher O82 Single delivery by caesarean section Treatment - Surgery Treatment - Surgery Control group: in control group the visceral and parietal peritoneum is closure Intervention group: in the intervention group visceral and parietal peritoneum non-closure. Hemorrhage. Timepoint: During surgery and after surgery. Method of measurement: Measuring the volume of blood in the suction AND the weight of blood-stained gases during surgery AND Measuring dressing weight when changing after surgery. Pain. Timepoint: 2-4-12-24 hours after surgery. Method of measurement: Use the pain Visual Analogue Scale (VAS). Fever. Timepoint: 2-4-12-24 hours after surgery. Method of measurement: use of Medical Thermometer. Infection. Timepoint: A week after surgery. Method of measurement: Patient file information. Ileus. Timepoint: after surgery. Method of measurement: Intestinal sounds, The first time the Stool. Hamedan University of Medical Sciences Approved 2019-03-09 Ethics committee of Hamedan University of Medical Sciences Shahid Fahmidah Street, Hamedan University of Medical Sciences and Health Services Hamedan Hamadan Iran (Islamic Republic of)