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IRCT2015042521917N2 IRCT 2015-06-09 Vice chancellor for research, Tabriz University of Medical Sciences The effect of using abdominal binder on clinical outcomes of cesarean section Comparison of the effects using abdominal binder and routine medical care on clinical outcomes of cesarean section: a randomized controlled trial 2015-06-22 anticipated 178 Complete https://irct.ir/trial/19055 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Cesarean. Intervention 1: Intervention group: After cesarean delivery, in addition to routine medical cares, the patient's abdomen will be fastened by Paksaman Abdominal Binder produced by Iran For intervention group. For application of appropriate abdominal binder, the women abdomen will be measured by standard meter at first, then, according to the abdomen circumference, abdominal binder with 5% reduction in abdominal circumference will be fastened for two days. At the end of each shift, abdominal binder will be assessed and opened from 10 P.M to 8 A.M. Intervention 2: The control group will receive routine medical cares and medicine.
public Sevil Hakimi
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) +98 41 3479 6770 Hakimis@tbzmed.ac.ir, hakimisevil@gmail.com Tabriz University of Medical Sciences scientific Sevil Hakimi
Nursing & Midwifery Faculty, South Shariati Street
Tabriz Iran (Islamic Republic of) +98 41 3333 5731 Hakimis@tbzmed.ac.ir, hakimisevil@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: First or second parity; elective cesarean section; 18 to 35 years old; having literacy; term pregnancy, singleton and without complicated pregnancy; fannenstiel incision on the skin and Kerr Incision on the uterine; hemoglobin more than 11 g/dl during Pregnancy; no history of substance abuse and smoking; no presence of placenta previa or placenta accreta, Incerta, Percreta at ultrasound; no rupture of membrane more than 6 Hours; permission of gynecologist. Exclusion criteria: Intolerance of abdominal binder by participant; no tendency to continue the study; presence of essential disease based on mother`s report; increasing the duration of surgery more than one hour; simultaneous surgery such as hysterectomy, myomectomy and tubectomy; preeclampsia or eclampsia; presence of severe bleeding or bleeding leading to hysterectomy; presence of hemorrhagic disorders or use of anticoagulant drugs such as heparin or warfarin; tissues damage during cesarean delivery. 18 years 35 years Female O82.0 Delivery by elective caesarean section Treatment - Other Other Intervention group: After cesarean delivery, in addition to routine medical cares, the patient's abdomen will be fastened by Paksaman Abdominal Binder produced by Iran For intervention group. For application of appropriate abdominal binder, the women abdomen will be measured by standard meter at first, then, according to the abdomen circumference, abdominal binder with 5% reduction in abdominal circumference will be fastened for two days. At the end of each shift, abdominal binder will be assessed and opened from 10 P.M to 8 A.M. The control group will receive routine medical cares and medicine. Pain. Timepoint: Baseline, 6, 12, 18, 24, 48 hours and fifth day after intervention. Method of measurement: Visual Analogous Scale (VAS). Distress. Timepoint: Baseline, 24 and 24 hours after intervention. Method of measurement: Symptom Distress Scale. Hemoglobin and hematocrit levels. Timepoint: Baseline and 36 hours after intervention. Method of measurement: hemoglobin and hematocrit. Healing of scar. Timepoint: Fifth day after cesarean section. Method of measurement: REEDA scale. Consumed painkiller. Timepoint: 48 hours after cesarean section. Method of measurement: Calculation of number of consumed painkiller. Satisfaction of participants. Timepoint: Fifth day after Cesarean. Method of measurement: Questionnaire. Vice chancellor for research, Tabriz University of Medical Sciences Approved 2015-04-13 Ethics committee of Tabriz University of Medical Sciences Faculty of Nursing & Midwifery, South Shariati Street Tabriz Iran (Islamic Republic of)