Seventy women were enrolled in this randomized clinical trial conducted from August 2019 to May 2020 at Yas Hospital affiliated with Tehran University of Medical Sciences.
Women were included who were candidates for an elective CS and aged between 18 and 40 years. Exclusion criteria included multiple pregnancies, emergency CS, placenta previa, placenta accrete, preeclampsia, morbid obesity, ASA class ≥ III, abnormal amniotic fluid, fetal anomalies, intrauterine growth restriction (IUGR), and macrosomia.
All participants were fully informed of the purposes of the study. Their understanding was checked, and informed consent was obtained before enrollment. The study was approved by the Local Ethics Committee of Tehran University of Medical Sciences (code: IR.TUMS.MEDICINE.REC.1397.358) and registered on the Iranian Registry of Clinical Trials website (code: IRCT20190130042559N1).
A specialist nurse used a simple randomization process to assign 70 women into 2 groups.
In group 1, the uterus was moved to the left manually by a qualified and competent anesthesiologist. This was undertaken shortly after induction with spinal anesthesia and while the patient was in the supine position. Standard operating procedures and guidelines were followed at all times. Infection prevention and aseptic techniques were used. There were no adverse events. The procedure involved the anesthesiologist placing his hand on the highest border of the uterus until the baby was delivered. In group 2, no uterus displacement was performed during CS.
The standard procedure followed for all included cardiorespiratory monitoring, such as non-invasive electrocardiogram (ECG), blood pressure (BP), pulse rate, and pulse oximetry (SpO2). The women were cannulated using an 18-gauge IV line before having ondansetron (4 mg), and Ringer’s lactate solution (500 mL) was administered 15 to 20 minutes before the spinal anesthesia. Oxygen was administered using a face mask delivered a flow rate of 5 L/min. The spinal anesthesia was administered between L4-L5 using a 27-gauge Quincke tip spinal needle in the sitting position. Also, 12.5 mg of bupivacaine (5%) was given.
Cardio-respiratory observations were recorded prior to the sitting position for the spinal anesthesia, then every 1 minute for the first 5 minutes after the spinal injection, then every 3 minutes until after the delivery of the baby, and then every 5 minutes until the end of surgery. Particular attention was paid to record observations right after the spinal anesthesia, before the surgical incision, before the uterus was incised, and then after the delivery of the baby.
Ephedrine was injected to increase systolic blood pressure (SBP); 10 mg was given if SBP was < 85 mm Hg, if it decreased > 30% of basic SBP, if there was agitation, and if the SpO2 was < 94%. If the pulse rate was < 60 per minute or < 30% of the average, atropine was injected (0.6 mg).
At the end of surgery, we asked surgeons to score access to the field of surgery (1, poor; 2, moderate; 3, good; 4, perfect).
SPSS version 22 (SPSS Inc, Chicago, Ill, USA) was used to analyze all data. Data were represented as the mean ± SD for continuous data and as a frequency for categorical variables. The independent samples t-test and Fisher exact test were used to compare quantitative and qualitative variables. Repeated measure analysis of variance (ANOVA) was also applied. P values less than 0.05 were considered significant.