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IRCT20180411039267N2 IRCT 2019-06-19 Tabriz University of Medical Sciences A comparison of the effect of Ringer Lactate versus Sodium Chloride 0.9% on maternal and neonatal acid- base state in cesarean A comparison of the effect of Ringer Lactate versus Sodium Chloride 0.9% on maternal and neonatal acid- base state in elective cesarean delivery 2019-06-01 anticipated 48 Complete https://irct.ir/trial/32026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random numbers table, they will be randomly divided into two groups of 24 people in the study and 24 people in the control group. In such a way that in the event of odd, they would be in Ringer Lactate and in the event of even, they would be in Sodium Chloride 0.9% group, Blinding description: The administration of anesthesia and fluids (volume and type of serum) during anesthesia is performed by an anesthesiologist and anesthesia technician, and all data will be collected and recorded in the checklist by an anesthesiologist who is unaware of the division of the groups. Pregnant women undergoing cesarean section are also unaware of the division of the groups. 3 Intraoperative fluid therapy, maternal and neonatal acid- base state, elective cesarean delivery. Intervention 1: Intervention group: In 24 pregnant women, infusion of lactate ringer serum with dose of volume therapy rule(Deficit+ Maintenance+ Loss+ Third space+ Compensated volume expansion) will begin before surgery and will continue until delivery of mother to the ward. Intervention 2: Control group: In 24 pregnant women, infusion of Sodium Chloride 0.9% serum with dose of volume therapy rule(Deficit+ Maintenance+ Loss+ Third space+ Compensated volume expansion) will begin before surgery and will continue until delivery of mother to the ward. 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 The study is not ended.
public Reyhaneh Abri
Department of Anesthesiology, Alzahra Hospital, South Artesh Street
Tabriz Iran (Islamic Republic of) 5174815811 +98 41 3553 9163 reyhane.abri@gmail.com Tabriz University of Medical Sciences scientific Reyhaneh Abri
Operating room-alzahra hospital- south artesh st
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3476 7121 reyhane.abri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Term parturient (pregnancy age more than 37 weeks) with physical status II ASA class candidates for elective cesarean section with spinal anesthesia Age range 18 to 45 years old In Tabriz Alzahra hospital Informed consent 18 years 45 years Female Any contraindication of regional anesthesia Gestational hypertension, preeclampsia, eclampsia, HELLP syndrome Hypersensitivity to local anesthetics Morbid obesity Maternal co-existing disease such as a history of heart disease, pulmonary, liver and kidney disease Emergency cesarean section like fetal bradycardia, placenta previa or other conditions of peripartum hemorrhage Treatment - Other Treatment - Other Intervention group: In 24 pregnant women, infusion of lactate ringer serum with dose of volume therapy rule(Deficit+ Maintenance+ Loss+ Third space+ Compensated volume expansion) will begin before surgery and will continue until delivery of mother to the ward. Control group: In 24 pregnant women, infusion of Sodium Chloride 0.9% serum with dose of volume therapy rule(Deficit+ Maintenance+ Loss+ Third space+ Compensated volume expansion) will begin before surgery and will continue until delivery of mother to the ward. Maternal acid- base state during elective cesarean. Timepoint: In operating room before the spinal anesthesia and after surgery (in recovery), an arterial blood sample will be analyzed for arterial blood gases (ABG). Method of measurement: In the ABG sample, the factors PH, HCO3, Base Excess, PCO2, Po2, Hb, Hct will be analyzed and will be recorded in the checklist for this purpose. Neonatal acid- base state during elective cesarean. Timepoint: Immediately after delivery and the umbilical cord closure, an umbilical artery blood sample will be sent for analysis of arterial blood gas (ABG). Method of measurement: In the ABG sample, the factors PH, HCO3, Base Excess, PCO2, Po2, Hb, Hct will be analyzed and will be recorded in the checklist for this purpose. Tabriz University of Medical Sciences Approved 2018-04-16 Ethics committee of Tabriz University of Medical Sciences Department of Anesthesiology, Alzahra hospital, South artesh street Tabriz East Azarbaijan Iran (Islamic Republic of)