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IRCT20120430009593N13 IRCT 2020-03-09 Shahid Beheshti University of Medical Sciences Determination of oxytocin dose based on “rule of threes” algorithm and Williams guideline in the elective cesarean delivery Evaluation and comparison of administrated oxytocin dose based on “rule of threes” algorithm with Williams guideline in the elective cesarean delivery 2016-09-22 anticipated 110 Complete https://irct.ir/trial/37580 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: • Randomization method: Simple randomization • Randomization Unit: based on patient • Randomization Tool: Random Number Table - block stratified randomization software wnidow version 6.0 Using this software, a random number table is created and the sample list is divided into two groups of 30 each, Blinding description: Participants enter two treatment groups based on a random number table. There is also a ready-made package available to the physician and nurse, including 55 packages of the first and 55 packages of the second drug. The data monitoring committee was also blinded of the grouping. 3 Elective cesarean delivery. Intervention 1: Intervention group:The patients in “rule of threes” algorithm group received Bolus oxytocin 3IU/3ml (0.9% saline) . At 3 and 6 min, an “inadequate” uterine tone assessment resulted in repeated bolus administration of oxytocin . At 9 min, an “inadequate” uterine tone assessment resulted in intramuscular injection of methylergonovine (0.2 mg /ml). At 15 min, inadequate uterine tone assessment resulted in administration of misoprostol 600 µg buccaly. Intervention 2: Intervention group: The William`s group received Bolus oxytocin 3 ml 0.09 % saline and then oxytocin infusion by pump at 15 ml/min until adequate uterine tonocity achieved then followed by 1-2 ml/min until patient entrance to recovery. At delivery, 3, 6, 9, 12, and 15 min postpartum, the patients were asked if they had flushing, nausea, chest pain, headache, ECG changes such as ST-T wave changes and other complaints. To nausea prophylaxis, all patients received ondansetron 4 mg intravenously after the delivery. Total administrated oxcytocin for both groups was finally recorded and then compared. Yes - There is a plan to make this available What will be shared: Some of data can be shared. When: Get 6 months after publishing To whom: محققین دانشگاهی و کلینیسن ها Conditions: For more research Where to obtain: Via email: y.ghorbani.m@gmail.com How to obtain: After publication Comments:
public Elham Memari
University Blvd, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 77557840 drmemary@gmail.com Shahid Beheshti University of Medical Sciences scientific Yousef Ghorbani
Velenjak, University Blvd
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9781 mpajouhesh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The women who undergoing to the first to third elective Cesarean delivery with spinal anesthetic technique American Society of Anesthesiologists (ASA) physical status I–II no limit no limit Female Labor pain The presence of maternal risk factors for uterine atony The presence of fetal risk factors for uterine atony Diabetes melitus Thrombocytopenia<100000 per microliter Uterine fibroma O82 Encounter for cesarean delivery without indication Treatment - Drugs Treatment - Drugs Intervention group:The patients in “rule of threes” algorithm group received Bolus oxytocin 3IU/3ml (0.9% saline) . At 3 and 6 min, an “inadequate” uterine tone assessment resulted in repeated bolus administration of oxytocin . At 9 min, an “inadequate” uterine tone assessment resulted in intramuscular injection of methylergonovine (0.2 mg /ml). At 15 min, inadequate uterine tone assessment resulted in administration of misoprostol 600 µg buccaly. Intervention group: The William`s group received Bolus oxytocin 3 ml 0.09 % saline and then oxytocin infusion by pump at 15 ml/min until adequate uterine tonocity achieved then followed by 1-2 ml/min until patient entrance to recovery. At delivery, 3, 6, 9, 12, and 15 min postpartum, the patients were asked if they had flushing, nausea, chest pain, headache, ECG changes such as ST-T wave changes and other complaints. To nausea prophylaxis, all patients received ondansetron 4 mg intravenously after the delivery. Total administrated oxcytocin for both groups was finally recorded and then compared. Creating of adequate uterine tonicity. Timepoint: at 3, 6, 9, 12, and 15 min after onset of surgery. Method of measurement: Uterine tonicity was evaluated as atonic, partial tonicity, adequate tonicity, well contracted and very well contracted by obstetrician. The time of administrated oxytocin to obtain adequate tonicity. Timepoint: At 3, 6, 9, 12, and 15 minute after onset of cesarean. Method of measurement: The mean administrated oxytocin. Shahid Beheshti University of Medical Sciences Approved 2018-07-10 The ethical commite of Shahid Beheshti Medical University Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Ebne Yaman St, Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)