Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial.

BACKGROUND: The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery. METHODS: A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group. RESULTS: No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay. CONCLUSION: The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. TRIAL REGISTRATION: All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.

Effect of direct current pulse stimulating acupoints of JiaJi (T10-13) and Ciliao (BL 32) with Han's Acupoint Nerve Stimulator on labour pain in women: a randomized controlled clinical study.

OBJECTIVE: To assess the clinical effect and safety of direct current (DC) pulse produced by Han's Acupoint Nerve Stimulator in reduction (HANS) of labor pain. METHODS: Totally 120 participants were enrolled in this clinical trial, and were randomly divided into 4 groups including: HANS group, patient controlled intravenous analgesia (PCIA) group, patient-controlled epidural analgesia (PCEA) group and control group. The HANS group was treated by stimulating the acupoints of JiaJi (T10-L3) and Ciliao (BL 32) with DC pulse of 100 Hz and 15-30 mA produced by a portable battery-powered Han's Acupoint Nerve Stimulator for 30 min. The PCIA group was intravenously infused Ondansetron (8 mg) for 5 min, then tramadol injection (1.5 mg/kg) was slowly dripped by using BaxterAP II electronic pump with 50 mL tramadol (0.70%) + ondansetron (8 mg), background infusion 2 mL/h, PCA dose of 2 mL, lockout interval of 10 min. In PCEA group, women received intrathecal injection ropivacaine (3 mg) in L2-3, and epidural catheter was connected to BaxterAP II electronic pump, with 100 mL Ropivacaine (0.1%) and Sufentanil (50 ug), background infusion 5 mL, Patient controlled analgesia (PCA) dose of 5 mL, lockout interval of 10 min. The control group was not received analgesia. The visual analogue scale (VAS), stage and manner of labor, Apgar score of newborn, neonatal weights, oxytocin dosage, postpartum hemorrhage and side effects were monitored in all groups. RESULTS: The vital signs were all stable in the four analgesic groups. After analgesia, there was statistical difference in VAS score between HANS group and control group, between PCEA group and the control group, between PCIA group and control group. The analgesic effect in the PCEA group was significantly better than that of other two groups. The second stage of labor in the PCEA group was longer than the other three groups, showing significant difference between them. The Apgar score of newborn 1 min after birth in the PCIA group was slightly lower than that of the other two groups, showing significant difference between them. The neonatal weights between four groups were not significantly different. The rate of cesarean section in the control group was significantly higher than that of the labor analgesia group, there was statistically difference in four groups. The number of PCIA group that used oxytocin was lower than that of other three groups. There was no significant difference in postpartum hemorrhage between four groups. The side effects of the PCEA group were itching, uroschesis and neonatal asphyxia and PCIA group were nausea and vomiting and neonatal asphyxia. However, fewer side-effects were observed in the HANS group. CONCLUSION: The DC pulse produced by HANS may be a non-pharmacological alternative to labor pain with fewer side effects.