Safety and efficacy of Ninjin'yoeito along with iron supplementation therapy for preoperative anemia, fatigue, and anxiety in patients with gynecological disease: an open-label, single-center, randomized phase-II trial
BMC women's health. 2022;22(1):229
BACKGROUND Preoperative anemia affects perioperative outcomes and often causes fatigue and psychological disorders. Therefore, anemia should be treated before a patient undergoes surgery. Ninjin'yoeito (NYT), a Japanese Kampo medicine composed of ginseng and Japanese angelica root with the other 10 herbs, is administered for anemia, fatigue and anxiety; however, there are a few reports that have prospectively examined the effects of NYT before surgery for gynecological diseases. Hence, we tended to investigate its efficacy and safety. METHODS In this open-label randomized trial, women with gynecological diseases accompanied by preoperative anemia (defined as < 11.0 g/dL Hemoglobin [Hb]) were randomly assigned (1:1) into the iron supplementation and NYT groups. Patients of the iron supplementation group and the NYT group received 100 mg/day iron supplementation with and without NYT (7.5 g/day) for at least 10 days before surgery. The primary endpoint was improvement in Hb levels before and after treatment, and Cancer Fatigue Scale (CFS) and Visual Analogue Scale for Anxiety (VAS-A) scores between groups. Statistical analyses were performed with Wilcoxon signed rank test, Wilcoxon rank sum test, and Fisher's exact test as appropriate. RESULTS Forty patients were enrolled of whom 30 patients were finally analyzed after allocating 15 to each group. There was no difference in the characteristics between both groups. Hb significantly increased in both groups (iron supplementation group, 9.9 ± 0.8 g/dL vs. 11.9 ± 1.6 g/dL; NYT group, 9.8 ± 1.0 g/dL vs. 12.0 ± 1.0 g/dL); the difference in the elevations in Hb between both groups was statistically insignificant (P = 0.72). Contrarily, CFS (17.9 ± 10.2 vs. 8.1 ± 5.2) and VAS-A (56 mm (50-70) vs. 23 mm (6-48)) scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014). Liver dysfunction occurred in one patient of the NYT group. CONCLUSIONS For treating preoperative anemia in women with gynecological conditions, NYT administration along with iron supplementation safely and efficiently improved the preoperative fatigue and anxiety in addition to the recovery from anemia. TRIAL REGISTRATION jRCT1051190012 (28/April/2019, retrospectively registered).
The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section
BMC pregnancy and childbirth. 2022;22(1):160
BACKGROUND The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications. METHOD Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels. RESULTS The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05). CONCLUSION There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution. TRIAL REGISTRATION ChiCTR1800015684 , 2018.4.15.
Combined Efficacy of Balloon Occlusion and Uterine Artery Embolization on Coagulation Function in Patients with High-Risk Placenta Previa during Cesarean Section
International journal of clinical practice. 2022;2022:7750598
PURPOSE The present study was performed in order to investigate the conbined effect of balloon occlusion and uterine artery embolization on coagulation function in patients with high-risk placenta previa during cesarean section. METHODS There involved a total of 38 patients with high-risk placenta previa undergoing cesarean section in our hospital from August 2019 to January 2021. The patients enrolled were randomly divided into study group (19 cases, receiving balloon occlusion combined with uterine artery embolization) and control group (19 cases, receiving conventional cesarean section). The operation time, intraoperative blood loss, plasma injection volume and hospital stay of the two groups were recorded. Moreover, the postoperative coagulation function indexes, including thrombin time (TT), fibrinogen (FBI), activated partial thromboplastin time (APTT) and prothrombin time (PT), were monitored and compared. Neonatal Apgar score and postoperative complications of the two groups were regarded as parameters for comparison. RESULTS The intraoperative blood loss, plasma injection volume and hospital stay of the study group were significantly lower compared with the control group (P < 0.05), whereas the operation time of the two groups was comparable (P > 0.05). Compared with the control group, the levels of TT, APTT and PT were lower while the level of FBI was higher in the study group (P < 0.05). The Apgar 1-min and 5-min scores of newborns were compared between the two groups (P > 0.05). However, the incidence of postoperative complications in the study group showed evidently lower outcomes compared with the control group (P < 0.05). CONCLUSION The combined approach of balloon occlusion and uterine artery embolization offered potential for improving the coagulation function of patients with high-risk placenta previa during cesarean section. In addition, the approach reduced the amount of blood loss and plasma injection, shortened the length of hospital stay, which was believed available for wide clinical application.
Optimal dose of misoprostol combined with oxytocin for preventing postpartum hemorrhage in cesarean section: A randomised controlled trial
Annals of medicine and surgery (2012). 2022;78:103931
BACKGROUND The study analyzed an optimal misoprostol dosage in prevention of postpartum hemorrhage (PPH). Also evaluated the side effects that might be related to dose of misoprostol. MATERIAL AND METHODS A randomised study was performed in mothers who received cesarean section. Participants were divided into 3 groups of 400, 600 and 800 μg intrauterine misoprostol insertion combined with oxytocin. Clinical characteristics, laboratory testing and operative data were collected. The primary outcome was the amount of intra-operative blood loss and side effects were assigned as a secondary outcome. RESULTS There were 357 eligible cases, 119 cases in each group equally. Baseline characteristics were similar in between groups. Higher misoprostol dosage demonstrated lower blood loss. Mean blood loss was 509.1, 465.7 and 441.1 ml in the 400, 600 and 800 μg misoprostol groups respectively which were significant difference (p value 0.027). Post-hoc pairwise t-tests found that 800 μg group diminished blood loss than 400 μg group (p value 0.004). Intra-operative blood loss ≥500 ml occurred less frequently in patients receiving higher misoprostol dosage (p value 0.035). However, PPH was not identified difference between groups (p value 0.707). Nausea and vomiting were complained in less than 1% while none of the cases exhibited shivering. Pyrexia was identified in all groups, however, there was a trend towards lower dosage related to less percentage of pyrexia. CONCLUSIONS Either 400, 600 or 800 μg of misoprostol can prevent PPH similarly. However, the study prefers 400 μg misoprostol because of minimization the side effects.
Tranexamic Acid for Prevention of Hemorrhage in Elective Repeat Cesarean Delivery - A Randomized Study
American journal of obstetrics & gynecology MFM. 2022;:100573
BACKGROUND The American College of Obstetricians and Gynecologists states that data is insufficient to recommend Tranexamic acid (TXA) prophylaxis for postpartum hemorrhage. OBJECTIVE This study's objective was to evaluate if prophylactic TXA reduces calculated blood loss versus placebo in women undergoing elective repeat cesarean delivery. STUDY DESIGN A double-blind, randomized, placebo-controlled trial, examining calculated blood loss with prophylactic doses of 1-gram of TXA given before skin incision and after placental delivery and standard uterotonics in women with singleton pregnancies at least 37 weeks' gestation, presenting for their second or third cesarean delivery under neuraxial anesthesia. The primary outcome was calculated blood loss at 24 hours. The calculation was based on the participant's height, weight, and the difference in hematocrit before the start of surgery and 24 hours after delivery. Prespecified secondary outcomes were quantification of maternal coagulation activity during the perioperative course. A sample size of 50 women per group was planned (N=100), based on a meta-analysis of mean reduction in blood loss after TXA. RESULTS 723 women were screened, and 110 women were randomized as follows: 55 to TXA and 55 to placebo. The primary outcome of mean calculated blood for TXA (2274 ± 469 mL) and the placebo group (2407 ± 388 mL), p > 0.05. In the secondary outcomes, D-dimer levels were lower in the TXA group than the placebo group 24 hours after delivery (2.1 ± 1.2 µg/mL versus 4.3 ± 2.4 µg/mL), p < 0.001. CONCLUSIONS Prophylactic tranexamic acid did not decrease mean calculated blood loss. Significantly less participants had calculated blood loss greater than 2000 mL in the tranexamic acid group compared to the placebo group with lower levels of D-dimer at 24 hours.
Women undergoing elective repeat caesarean delivery (n= 110).
Prophylactic doses of tranexamic acid (TXA) before skin incision and after placental delivery (n= 55).
Standard uterotonics (n= 55).
The mean calculated blood loss for TXA was 2,274 ± 469 mL, and for standard uterotonics was 2407 ± 388 mL. D-dimer levels were lower in the TXA group than the placebo group 24 hours after delivery (2.1 ± 1.2 µg/mL vs. 4.3 ± 2.4 µg/mL).
Intravenous Tranexamic acid versus placebo during Caesarian section: A comparative study
Pakistan journal of medical sciences. 2022;38(5):1183-1187
OBJECTIVES To evaluate the effectiveness of Tranexamic Acid in preventing postpartum hemorrhage against placebo in high-risk women undergoing cesarean section. METHODS A double-blinded placebo-controlled comparative trial was conducted at the Obstetrics and Gynecology Department of Nishtar Hospital for one year, from 15(th) June 2020 to 15(th) June 2021. A total of 60 women who were at high risk of postpartum hemorrhage and had to undergo elective cesarean sections were included in the study. Among them, initial 30 patients were administered Tranexamic Acid before skin incision whereas later 30 were treated as the placebo group. These women were then observed for blood loss during surgery and within 24 hrs. after surgery and any postoperative complications such as thromboembolic events, the need for additional uterotonic agents, and blood transfusions. RESULTS Out of 60 women, 30 were placed in each group. The groups had no significant difference in terms of baseline data and post-partum hemorrhage-associated risk factors (p>0.05). However, the occurrence rate of primary post-partum hemorrhage (blood loss greater than 1000 ml) was significantly less in a tranexamic acid group than the placebo group (16.6% vs 60%, respectively, p<0.01). Similarly, the requirement of additional uterotonic agents (13.3% vs 43.3%, respectively) and the need for blood transfusion (6.0% vs 23.3%, respectively) was lower in a tranexamic group than in the placebo group. CONCLUSION The study highlighted the significance of tranexamic acid in controlling post-partum hemorrhages, the requirement of additional uterotonic agents, improving post-partum hemoglobin, and the need for blood transfusion.
Electrocoagulation versus gelantine-thrombin matrix sealant for haemostasis after laparoscopic surgery of ovarian endometriomas: a randomised control trial (abridged secondary publication)
Hong Kong medical journal = Xianggang yi xue za zhi. 2022;28 Suppl 3(3):43-44
Perioperative prophylactic internal iliac artery balloon occlusion for prevention of postpartum haemorrhage in placenta praevia: a randomised controlled trial (abridged secondary publication)
Hong Kong medical journal = Xianggang yi xue za zhi. 2022;28 Suppl 1(1):23-26
Epidural anaesthesia and myomectomy-associated blood loss: - a prospective randomised controlled study
Ginekologia polska. 2022
OBJECTIVES The management of anaesthesia for patients with large myomas is particularly important due to disruption of hemodynamic as a result of massive haemorrhage, the prolonged duration of surgery and requirement for additional interventions. This study evaluated the effect of anaesthetic technique on blood loss in patients undergoing myomectomy due to large fibroid uterus. MATERIAL AND METHODS A total of 156 patients that underwent myomectomy were randomized into two equal groups according to the type of anaesthesia: Epidural anaesthesia group and General anaesthesia group. The volume of blood loss and blood products transfusion was reviewed for each patient. RESULTS The intraoperative blood loss and need for blood transfusion were significantly higher in general anaesthesia group (p < 0.001). The mean hematocrit change was 2.5 ± 1.5 vs 3.7 ± 2.9 % (p = 0.001) for both groups. CONCLUSIONS In the myomectomy planning of women with a large fibroid uterus, the team of gynecologists and anaesthesiologists should take care to choose the most optimal technique for anaesthesia.
Calcium chloride for the prevention of uterine atony during cesarean delivery: A pilot randomized controlled trial and pharmacokinetic study
Journal of clinical anesthesia. 2022;80:110796
STUDY OBJECTIVE To assess the feasibility, patient tolerance, pharmacokinetics, and potential effectiveness of a randomized controlled trial protocol investigating intravenous calcium chloride for the prevention of uterine atony during cesarean delivery. DESIGN Double-blind, randomized controlled pilot trial with nested population pharmacokinetic analysis. SETTING This study was performed at Lucile Packard Children's Hospital, from August 2018 to September 2019. PATIENTS Forty patients with at least two risk factors for uterine atony at the time of cesarean delivery. INTERVENTIONS One gram of intravenous calcium chloride (n = 20 patients) or a saline placebo control (n = 20 patients), in addition to standard care with oxytocin, upon umbilical cord clamping. MEASUREMENTS The primary efficacy-related outcome was the presence of uterine atony defined as the use of a second-line uterotonic medication, surgical interventions for atony, or hemorrhage with blood loss >1000 mL. Blood loss, uterine tone numerical rating scores, serial venous blood calcium levels, hemodynamics, and potential side effects were also assessed. MAIN RESULTS The study protocol proved feasible. The incidence of atony was 20% in parturients who received calcium compared to 50% in the placebo group (relative risk 0.38, P = 0.07, 95% CI 0.15-1.07, NNT 3.3). Calcium recipients tolerated the drug infusion well, with no adverse events and an equal incidence of potential side effects in the calcium and placebo groups. Ionized calcium concentration rose significantly in all patients who received calcium infusion, from baseline 1.18 mmol/L to peak levels 1.50-1.60 mmol/L. One-compartment population pharmacokinetics established clearance of 0.93 (95% CI 0.63-1.52) L/min and volume of distribution 76 (95% CI 49-94) L. CONCLUSIONS In this pilot study, investigators found that intravenous calcium chloride was well-tolerated by the 20 patients assigned to receive the study drug and may be effective in prevention of uterine atony. A 1-g dose was sufficient to substantially increase calcium levels without any critically elevated lab values or concern for adverse side effects. These encouraging findings warrant further investigation of calcium as a novel agent to prevent uterine atony with an adequately powered clinical trial. Clinical trial registry NCT03867383 https://clinicaltrials.gov/ct2/show/NCT03867383.