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IRCT20211024052856N1 IRCT 2021-11-08 Esfahan University of Medical Sciences Evaluation of the effect of using abdominal binder on the amount of vaginal bleeding, pain intensity and mobility after cesarean section Evaluation of the effect of using abdominal binder on the amount of vaginal bleeding, pain intensity and mobility after cesarean section 2021-11-11 anticipated 184 Complete https://irct.ir/trial/59581 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using Random Allocation Software (M. Saghaei),patients were allocated using random blocks of four or six in a 1:1 ration to a group that received abdominal binders or a control group. Group assignments were written down and placed into sequentially numbered opaque envelopes.The allocation was performed by an individual. who was masked to enrollment, data collection.Following cesarean delivery and recording demographic data ,eligible patients’ names were written on envelopes; the envelopes were ultimately opened by one of the researchers and patients were then allocated to the intervention or control groups, Blinding description: The data analyzer is unaware of the division of the samples into the control and intervention groups. N/A Delivery by elective cesarean section. Intervention 1: In the intervention group, in addition to routine care, the patient's abdomen will be closed with a abdominal binder( Paksaman, made in iran) after cesarean section, besides receiving routine care and with regard to a 10% reduction of abdominal circumference. For application of the appropriate abdominal binder, the women’s abdomen measured by standard meter first; then, according to the abdominal circumference, in abdominal circumference fastened for 24 houre after transfer of the patient to the surgery ward. abdominal binder will close in 24 hours. At the end of each shift, the abdomen will be examined and will be open from 12 pm to 6 am. Intervention 2: Control group: they receive routine care and medication. Yes - There is a plan to make this available What will be shared: Individual participant data collected for the primary outcome measures When: After publication for one year To whom: For all people who request data Conditions: It is allowed to perform any analysis on the data, but use of data for publication is not allowed. Where to obtain: Corresponding author of article How to obtain: After requesting the data by email to corresponding author, the data will be sent after a maximum period of one week Comments:
public Soheila Bakhtiari
Isfahan University of Medical Sciences, Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7510 bakhtiari@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Soheila Bakhtiari
Isfahan University of Medical Sciences, Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7510 bakhtiari@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Spinal anesthesia Do not use anti-anxiety and hypnotic drugs and painkillers No underlying disease (neuromuscular disorders, hypertension, kidney disease, heart disease) BMI between 18/5 to 29/5 Term baby Uncomplicated pregnancy such as absence of eclampsia and preeclampsia Do not have any coagulation disorders or use anticoagulants Pfannenstiel incision on the skin and kerr incision on the uterus no limit no limit Female Intolerance of the abdominal binder by the patient Reluctance to continue participating in the study Severe postoperative bleeding Damage to body tissues during cesarean section such as damage to the urinary tract and gastrointestinal tract O82 Encounter for cesarean delivery without indication Treatment - Other Other In the intervention group, in addition to routine care, the patient's abdomen will be closed with a abdominal binder( Paksaman, made in iran) after cesarean section, besides receiving routine care and with regard to a 10% reduction of abdominal circumference. For application of the appropriate abdominal binder, the women’s abdomen measured by standard meter first; then, according to the abdominal circumference, in abdominal circumference fastened for 24 houre after transfer of the patient to the surgery ward. abdominal binder will close in 24 hours. At the end of each shift, the abdomen will be examined and will be open from 12 pm to 6 am. Control group: they receive routine care and medication Pain. Timepoint: 6 hours after intervention, 12 hours after intervention, 18 hours after intervention and 24 hours after intervention. Method of measurement: Visual analog scale. The amount of vaginal bleeding. Timepoint: Before intervention, 6 and 24 hours after intervention. Method of measurement: Measurement of hemoglobin and hematocrit using Complete Blood Count test. Mobility. Timepoint: 12 and 24 hours after the intervention. Method of measurement: Six minute walk test. Painkillers. Timepoint: 6, 12, 18 and 24 hours after the intervention. Method of measurement: Registration in the questionnaire based on patient records. Esfahan University of Medical Sciences Approved 2021-09-04 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences,Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)