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IRCT20190108042291N1 IRCT 2019-01-26 Iran University of Medical Sciences The Effects of Platelet-Rich Plasma (PRP) during cesarean section on the integrity and thickness of uterine scar. Evaluation of the Effects of Platelet-Rich Plasma (PRP) during cesarean section on the integrity and thickness of uterine scar 2019-01-21 anticipated 80 Complete https://irct.ir/trial/36794 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 80 pregnant women will be divided into two groups of 40 each using a computer-generated table of random numbers, Blinding description: Double blinding (blinding participants, and investigators consisting of statistician and specialist in sonography) will be used to reduce the selection bias. N/A Cesarean section surgery. Intervention 1: Intervention group: In this group, after the closure of the uterine myometrium incision, PRP will be directly applied to the uterine myometrium tissue whereas the control group received the usual care. PRP solution will be prepared based on the following steps: 1. Venous blood (30mL) will be drawn from the patient’s arm in anticoagulant-containing tubes; (the recommended temperature during processing is 21℃–24℃ to prevent platelet activation during centrifugation of the blood); 2. The blood will be centrifuged at 1,200 rpm for 12 minutes; 3. The blood separates into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells; 4. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube; 5. The upper two-thirds of the plasma will be discarded because it is platelet-poor plasma.6. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP; the PRP will be ready for injection. Approximately 30 mL of venous blood yields 3–5 mL of PRP.7. The prepared PRP solution will be transferred within sterile syringe from the laboratory to the OR 8. Then will be directly applied to the uterine myometrium tissue before skin closure. 9. The patients were examined by the physician on day one, day seven and at day 30 after the procedure. Intervention 2: Control group: In control group cesarean section incision will be closed by the conventional technique(without PRP injection). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Shahla Mirgaloybayat
Rasoul Akram Hospital, Satarkhan St, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 2680 mirgaloybayat.sh@iums.ac.ir Iran University of Medical Sciences scientific Shahla Mirgaloybayat
Rasoul Akram Hospital, Satarkhan St, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 2680 mirgaloybayat.sh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Emergency and non-emergency cesarean section for the first time no limit no limit Female Presence of uterine anomalies with or without previous repair Presence of uterine myoma at the site of caesarean incision History of myomectomy at site of caesarean incision Presence of placenta previa and placenta accrete Prolonged rupture of membranes without chorioamnionitis criteria (consist of fever, uterine tenderness…) Rupture of membranes with chorioamnionitis criteria (consist of fever, uterine tenderness…) O82.9 Delivery by caesarean section, unspecified Treatment - Surgery Treatment - Surgery Intervention group: In this group, after the closure of the uterine myometrium incision, PRP will be directly applied to the uterine myometrium tissue whereas the control group received the usual care. PRP solution will be prepared based on the following steps: 1. Venous blood (30mL) will be drawn from the patient’s arm in anticoagulant-containing tubes; (the recommended temperature during processing is 21℃–24℃ to prevent platelet activation during centrifugation of the blood); 2. The blood will be centrifuged at 1,200 rpm for 12 minutes; 3. The blood separates into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells; 4. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube; 5. The upper two-thirds of the plasma will be discarded because it is platelet-poor plasma.6. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP; the PRP will be ready for injection. Approximately 30 mL of venous blood yields 3–5 mL of PRP.7. The prepared PRP solution will be transferred within sterile syringe from the laboratory to the OR 8. Then will be directly applied to the uterine myometrium tissue before skin closure. 9. The patients were examined by the physician on day one, day seven and at day 30 after the procedure. Control group: In control group cesarean section incision will be closed by the conventional technique(without PRP injection). Uterine closure time. Timepoint: During the surgery. Method of measurement: Chronometer. Primary postpartum hemorrhage. Timepoint: During and the day after surgery. Method of measurement: Complete Blood Count(CBC). Pain. Timepoint: The day, week and month after surgery. Method of measurement: VAS scale. Infection rate. Timepoint: The day, week and month after surgery. Method of measurement: Thermometer. Residual myometrial thickness. Timepoint: 3 months after the surgery. Method of measurement: Ultrasound examination will be performed 3 months after the operation to assess the integrity of scar by measuring the residual myometrial thickness and the depth of the possible scar defect. The depth of cesarean section scar defect(thickness). Timepoint: 3 months after the surgery. Method of measurement: Ultrasound examination will be performed 3 months after the operation to assess the integrity of scar by measuring the residual myometrial thickness and the depth of the possible scar defect. Iran University of Medical Sciences Approved 2018-11-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)