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IRCT20260425069157N4 IRCT 2026-10-25 Oroumia University of Medical Sciences Evaluating the effect of left lateral tilt before and after spinal anesthesia on hemodynamic status of mothers undergoing elective cesarean section Comparision of hemodynamic effect in lateral tilt before and after spinal anesthesia during elective 2026-11-22 anticipated 110 Pending https://irct.ir/trial/94197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This is a parallel-group, randomized clinical trial that compares hemodynamic parameters between the two study groups at baseline and every 5 minutes until the end of surgery. The intervention consists of a positioning maneuver (applying a left lateral tilt before or after spinal anesthesia), Randomization description: Participants will be allocated to the intervention and control groups using block randomization with block sizes of 4 and 6 on an individual basis. Stratified randomization is not used. The random sequence will be generated using Random Allocation Software. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) will be utilized. Upon obtaining written informed consent and arrival in the operating room, the envelope corresponding to the patient’s number will be opened by an individual independent of the principal investigator to determine the intervention type (left lateral tilt before or after spinal anesthesia), Blinding description: This study is a double-blind randomized clinical trial. Due to the physical nature of the intervention (positioning tilt), blinding the patients and the attending anesthesiologist was not feasible. However, to minimize bias, both the outcome assessor (who recorded hemodynamic parameters without knowledge of group allocation timing) and the data analyst (who analyzed coded datasets as groups A and B) were blinded to group allocations. N/A Hypotension and bradycardia induced by spinal anesthesia during elective cesarean section. Intervention 1: Intervention group1: Application of a 15° left lateral tilt before spinal anesthesia. Intervention 2: Intervention group2: Application of a 15° left lateral tilt after spinal anesthesia. 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 I will make a decision to publish after the completion of the project and according to the results
public Dr. Roghayea Neisari
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 nisari.r@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Roghayea Neisari
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 nisari.r@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 40 years Term pregnancy (37-40 weeks of gestation) Candidate for elective (non-emergency) cesarean section Singleton pregnancy ASA physical status I or II Written informed consent to participate in the study 18 years 40 years Female History of known cardiovascular diseases or chronic hypertension Severe/morbid obesity (Body Mass Index [BMI] > 40 kg/m²) Preeclampsia or eclampsia Known history of allergy to local anesthetics Active bleeding Coagulation disorders (coagulopathy) Conversion or need for general anesthesia O29.2 Central nervous system complications of anesthesia during pregnancy Prevention Prevention Intervention group1: Application of a 15° left lateral tilt before spinal anesthesia Intervention group2: Application of a 15° left lateral tilt after spinal anesthesia Systolic Blood Pressure). Timepoint: Baseline (pre-intervention) and every 5 minutes until the end of surgery. Method of measurement: Standard operating room vital signs monitor. Diastolic Blood Pressure. Timepoint: Baseline (pre-intervention) and every 5 minutes until the end of surgery. Method of measurement: Standard operating room vital signs monitor. Mean Arterial Pressure (MAP). Timepoint: Baseline (pre-intervention) and every 5 minutes until the end of surgery. Method of measurement: Standard operating room monitor. Heart Rate. Timepoint: Baseline (pre-intervention) and every 5 minutes until the end of surgery. Method of measurement: Standard monitor (ECG / Pulse Oximetry). Incidence of Hypotension. Timepoint: From the onset of spinal anesthesia until the end of surgery. Method of measurement: Recorded via checklist; defined as a decrease of more than 20% from baseline blood pressure. Incidence of Bradycardia. Timepoint: From the onset of spinal anesthesia until the end of surgery. Method of measurement: Recorded via checklist; defined as a decrease of more than 20% from baseline heart rate. Oroumia University of Medical Sciences Approved 2026-09-16 Research Ethics Committees of Urmia University of Medical Sciences Urmia University of Medical Sciences., Emergency Alley., Resalat Boulevard., Urmia Urmia West Azarbaijan Iran (Islamic Republic of)