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1.
Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial)
Park, S. J., Lee, J. W., Hwang, D. W., Lee, S., Yim, G. W., Song, G., Lee, E. J., Kim, H. S.
In vivo (Athens, Greece). 2024;38(1):431-436
Abstract
BACKGROUND/AIM: Vasopressin injected during myomectomy is known to effectively reduce bleeding but is sometimes associated with intraoperative vasoconstriction and hypertension due to systemic absorption. Although there is a growing preference for the use of diluted vasopressin, evidence of its effect and safety is still lacking. PATIENTS AND METHODS We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during robot-assisted laparoscopic myomectomy (RALM), where a total of 39 women with uterine fibroids were randomly assigned into the following three groups (group 1, 0.2 IU/ml; group 2, 0.1 IU/ml; group 3, 0.05 IU/ml with a total of 100 ml of normal saline). The primary endpoint was to compare estimated blood loss (EBL), and the secondary endpoints were to compare postoperative value and drop ratio of hemoglobin, operation time, transfusion, hospitalization, and complications among the three groups. RESULTS There were no differences in the number and largest size of uterine fibroids, total weight of uterine fibroids, console time, and volumes of intravenous fluid administered during RALM among the three groups, whereas combined operation was performed more commonly in group 2 than in groups 1 and 3 (53.9% vs. 0 to 7.7%; p=0.01). The primary and secondary endpoints were also not different among the three groups. However, two patients in group 1 (15.4%) showed vasopressin-related hypertension. CONCLUSION Vasopressin diluted in a volume of 100 ml showed an effective hemostatic effect and safety during RALM (Trial No. NCT04874246 in ClinicalTrial.gov).
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2.
Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial
Ortuanya, K. E., Eleje, G. U., Ezugwu, F. O., Odugu, B. U., Ikechebelu, J. I., Ugwu, E. O., Eke, A. C., Awkadigwe, F. I., Ezenwaeze, M. N., Ofor, I. J., et al
Women's health (London, England). 2024;20:17455057231225311
Abstract
BACKGROUND Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN The study is a double-blind randomized controlled trial. METHODS The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.
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3.
Efficacy of Tranexamic Acid in Reducing Myomectomy-Associated Blood Loss among Patients with Uterine Myomas at Federal Teaching Hospital Abakaliki: A Randomized Control Trial
Olaleye, A. A., Adebayo, J. A., Eze, J. N., Ajah, L. O., Anikwe, C. C., Egede, J. O., Ebere, C. I.
International journal of reproductive medicine. 2024;2024:2794052
Abstract
BACKGROUND Myomectomy can be associated with life-threatening conditions such as bleeding. Excessive bleeding usually necessitates blood transfusion. Interventions to reduce bleeding during myomectomy will help reduce the need for blood transfusion with its associated complications. Tranexamic acid has been used to reduce bleeding in other surgical procedures, and its usage during myomectomy merits evaluation. OBJECTIVE To assess the efficacy of tranexamic acid in reducing myomectomy-associated blood loss. MATERIALS AND METHODS This is a prospective double-blinded randomized trial conducted on women who had abdominal myomectomy. Patients were randomized into two groups. The study group received perioperative intravenous tranexamic acid (TXA) while the control group received a placebo. Intraoperative blood loss was calculated by measuring the volume in the suction apparatus and weighing the surgical swabs. In addition, blood collected postoperatively from the wound drains and drapes were measured. Haemoglobin concentrations were determined preoperatively and on second postoperative day for all cases. Any adverse effect was noted in both groups. The data was processed using Epi Info software (7.2.1, CDC, Atlanta, Georgia). The relationships between categorical data were analyzed using X(2) and Student's t-test to determine relationships between continuous variables, with a P value of 0.05 considered statistically significant, and correlation coefficients were calculated using Pearson's formula, and probability of 0.05 was set for statistical significance. RESULTS Symptomatic uterine myomas constituted 17.3% of all gynaecological admissions and 21.3% of gynaecological operations at Federal Teaching Hospital Abakaliki. The mean intraoperative blood loss among patients that had perioperative tranexamic acid infusion was 413.6 ± 165.6 ml, while that of patients with placebo infusion was 713.6 ± 236.3 ml. Perioperative tranexamic acid infusion therefore reduced mean intraoperative blood loss by 300 ml, and this was statistically significant (SMD = -0.212, 95% CI: -403.932 to -196.067, P < 0.0001). Perioperative tranexamic acid reduced mean total blood loss by a value of 532.3 ml, and this is statistically significant (SMD = 30.622, 95% CI: 393.308 to 670.624, P < 0.0001). Tranexamic acid also improved postoperative haemoglobin concentration by 1.8 g/dl compared with placebo, and this is statistically significant (SMD = -0.122, 95% CI: 1.182 to 2.473, P < 0.0001). Tranexamic acid infusion decreased hospital stay by about 2 days, and this difference was statistically significant (SMD = -3.929, 95% CI: -3.018 to -0.983, P = 0.0003). There was no adverse drug reaction in the course of the study. CONCLUSION The use of tranexamic acid during myomectomy reduced intraoperative and postoperative blood loss. It is also associated with decreased hospital stay. This trial is registered with NCT04560465.
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4.
Reducing patient's perception of postoperative vaginal bleeding after laparoscopic hysterectomy via independent closure of the vaginal cuff angles (RCT)
Radtke, S., Arms, R., Son, M. A., Sanchez, S., Singh, V., Bencomo, M., McCall, E., Rodriguez, S., Olivas-Cardiel, K.
European journal of obstetrics, gynecology, and reproductive biology. 2024;294:111-116
Abstract
STUDY OBJECTIVE Determine if independently suturing the vaginal cuff angles in addition to running barbed suture has an effect on patients' perception of postoperative bleeding after laparoscopic hysterectomy. DESIGN Randomized controlled trial. SETTING University-based medical center. PATIENTS Females ages 18-60 undergoing laparoscopic hysterectomy. INTERVENTIONS Patients were randomly assigned to either cuff closure via single layer of barbed suture (control) vs adding figure-of-eight stitches at each angle (intervention). A survey was given between 10 and 25 days after surgery inquiring about bleeding and dyspareunia. A second survey was given between postoperative days 90-114. Chart review was performed to record emergency room visits, complications, infections, and reoperations during the first 90 postoperative days. RESULTS n = 117 patients were analyzed. 62 (control) and 55 (intervention). Groups were similar in terms of age (42.92 v 44.29p =.35), BMI (33.79 v 34.06p =.85), diabetes (5.26 % (3/55) v 15.09 % (8/53) p =.08) p =.97). Bleeding was decreased in intervention arm (24.19 % (15/62) v 9.09 % (5/55) p =.03). Median (IQR) pelvic pain score was similar (2.0 (0-5.0) v 2.0 (0-4.0) p =.26). Median total operative time (IQR) (129 min (102, 166) v 139 min (120, 163) p =.39) and median EBL (IQR) (50 mL (30-75) vs 50 mL (20-75) p =.43) were similar. Cuff closure in seconds (IQR) was higher in intervention group (373 sec (323, 518) v 571 sec (520, 715) p <.01). 8/60 control patients visited the ED (13.33 %) v 7/54 (12.96 %) p =.95. Readmissions (1.67 % (1/60) v 1.85 % (1/55) p = 1), re-operations (0 % (0/60) v 1.85 % (1/55) p =.47) and postoperative infections (5.0 % (3/60) v 1.85 % (1/54) p =.62) were similar. Secondary survey showed no significant difference in bleeding (15.38 % (4/26) v 4.35 % (1/23) p =.35) and SF-36 results were similar. CONCLUSION Independently suturing the vaginal cuff angles reduces patients' perception of vaginal bleeding in the early postoperative period. Incidence of complications, reoperations, and long-term quality of life are similar.
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5.
Tranexamic acid to reduce blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery-a randomized controlled trial
Neumann, B. G., Metgud, M. C., Hoffman, M. K., Patil, K., Savanur, M., Hanji, V., Ganachari, M. S., Somannavar, M., Goudar, S. S.
AJOG global reports. 2024;4(1):100316
Abstract
BACKGROUND Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied. OBJECTIVE This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage. STUDY DESIGN This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups. RESULTS A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (P<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (P<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (P<.001). No difference in the need for additional uterotonics (P=.26) or the need for postoperative parental iron (P=.18) was noted. No woman was transfused in either group. CONCLUSION High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.
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6.
Effectiveness of Autologous Platelet-Rich Plasma Therapy in Women with Repeated Implantation Failure: A Randomized Clinical Trial
Eftekhar, M., Neghab, N., Khani, P.
International journal of fertility & sterility. 2024;18(2):162-166
Abstract
BACKGROUND Platelet-rich plasma (PRP) therapy has been shown to enhance tissue regeneration by expressing several cytokines and growth factors (GFs). This study investigated the effect of intrauterine infusion of PRP as a noninvasive autologous GF on pregnancy outcomes in women with repeated implantation failure. MATERIALS AND METHODS This randomized clinical trial was conducted to compare the pregnancy rates between two groups of women who were candidates for the frozen-thawed embryo transfer with a history of two or more implantation failures. The PRP group (n=33) was treated with hormone replacement therapy+0.5 cc to 1 cc PRP infused into the uterine cavity two days before the embryo transfer. The control group (n=33) was only treated with hormone replacement therapy. The endometrial preparation process was done similarly in both groups. The chemical, clinical, and ongoing pregnancy, and implantation rates were compared between the two groups. RESULTS Our results showed that the chemical pregnancy rate was not statistically higher in the PRP group in comparison with the control group (36.4 vs. 24.2%). In addition, the clinical pregnancy, ongoing pregnancy, and implantation rates were higher in the PRP group than the control group; however, the difference between the two groups was not statistically significant. CONCLUSION Administration of intrauterine PRP before embryo transfer in women with repeated implantation failure (RIF) does not affect assisted reproductive technology (ART) outcomes (registration number: IRCT2016090728950N3).
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7.
Validation of three models for prediction of blood transfusion during cesarean delivery admission
Bruno, A., Federspiel, J. J., McGee, P., Pacheco, L., Saade, G., Parry, S., Longo, M., Tita, A., Gyamfi-Bannerman, C., Chauhan, S., et al
American journal of perinatology. 2023
Abstract
OBJECTIVE Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery. METHODS This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative (CMQCC)), and two regression models (Ahmadzia et al and Albright et al). The primary outcome was red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared. RESULTS Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low-risk, 5,259 (48.8%) as medium-risk, and 3,556 (33.0%) as high-risk with corresponding transfusion rates of 2.1% (95% CI 1.5-2.9%), 2.2% (95% CI 1.8-2.6%), and 7.5% (95% CI 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI 0.76-0.81) and 0.79 (95% CI 0.77-0.82), respectively (p=0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion. CONCLUSION Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S. COHORT Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed.
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8.
Comparative study between oxytocin and combination of tranexamic acid and ethamsylate in reducing intra-operative bleeding during emergency and elective cesarean section after 38 weeks of normal pregnancy
Bosilah, A. H., Eldesouky, E., Alghazaly, M. M., Farag, E., Sultan, E. E. K., Alazazy, H., Mohamed, A., Ali, S. M. S., Elsror, A. G. A., Mahmoud, M., et al
BMC pregnancy and childbirth. 2023;23(1):433
Abstract
OBJECTIVE Cesarean Section (CS) is associated with an increased risk of hemorrhage. Many drugs are used to decrease this risk. We aim to compare the combination of ethamsylate and tranexamic acid, oxytocin, and placebo in women undergoing CS. METHODS We conducted a double-blinded, randomized, placebo-controlled trial between October and December 2020 in four university hospitals in Egypt. The study included all pregnant women in labor without any complications who accepted to participate in the study between October and December 2020. The participants were divided into three groups. The subjects were randomly allocated to receive either oxytocin (30 IU in 500 ml normal saline during cesarean section), combined one gram of tranexamic acid with 250 mg of ethamsylate once before skin incision, or distilled water. Our main outcome was the amount of blood loss during the operation. The secondary outcomes were the need for blood transfusion, hemoglobin and hematocrit changes, hospital stay, operative complications, and the need for a hysterectomy. The one-way ANCOVA test was used to compare the quantitative variables between the three groups while the Chi-square test was used to compare the qualitative variables. Post hoc analysis then was performed to compare the difference between every two groups regarding the quantitative variables. RESULTS Our study included 300 patients who were divided equally into three groups. Tranexamic acid with ethamsylate showed the least intra-operative blood loss (605.34 ± 158.8 ml) compared to oxytocin (625.26 ± 144.06) and placebo (669.73 ± 170.69), P = 0.015. In post hoc analysis, only tranexamic acid with ethamsylate was effective in decreasing the blood loss compared to placebo (P = 0.013); however, oxytocin did not reduce blood loss compared to saline (P = 0.211) nor to tranexamic acid with ethamsylate (P = 1). Other outcomes and CS complications showed no significant difference between the three groups except for post-operative thrombosis which was significantly higher in the tranexamic and ethamsylate group, P < 0.00001 and the need for a hysterectomy which was significantly increased in the placebo group, P = 0.017. CONCLUSION The combination of tranexamic acid and ethamsylate was significantly associated with the least amount of blood loss. However, in pairwise comparisons, only tranexamic acid with ethamsylate was significantly better than saline but not with oxytocin. Both oxytocin and tranexamic acid with ethamsylate were equally effective in reducing intra-operative blood loss and the risk of hysterectomy; however, tranexamic acid with ethamsylate increased the risk of thrombotic events. Further research with a larger number of participants is needed. TRIAL REGISTRATION The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202009736186159 and was approved on 04/09/2020.
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9.
Minimizing blood loss in laparoscopic myomectomy with temporary occlusion of the hypogastric artery
Balulescu, L., Nistor, S., Lungeanu, D., Brasoveanu, S., Pirtea, M., Secosan, C., Grigoras, D., Caprariu, R., Pasquini, A., Pirtea, L.
Frontiers in medicine. 2023;10:1216455
Abstract
INTRODUCTION Uterine leiomyomas are common benign pelvic tumors. Currently, laparoscopic myomectomy (LM) is the preferred treatment option for women in the fertile age group with symptomatic myomas. The authors hypothesize that combining LM with a bilateral temporary occlusion of the hypogastric artery (TOHA) using vascular clips minimizes uterine blood flow during surgery and can significantly reduce surgery-associated blood loss. MATERIALS AND METHODS This single-center, prospective randomized study was conducted at the Department of Obstetrics and Gynecology, Municipal Emergency Clinical Hospital Timisoara, Romania. Patients aged between 18 and 49 who preferred laparoscopic myomectomy and wished to preserve fertility were included, provided they had intramural uterine leiomyomas larger than 4 cm in diameter that deformed the uterine cavity. The study analyzed data from 60 laparoscopic myomectomies performed by a single surgeon between January 2018 and December 2020. Patients were randomly assigned to either: "LM + TOHA" group (29 patients), and "LM" group (31 patients). The study's main objective was to evaluate the impact of TOHA on perioperative blood loss, expressed as mean differences in Hb (delta Hb). RESULTS Delta Hb was statistically lower in the "LM + TOHA" group compared to "LM" group, with mean ± standard (min-max): 1.68 ± 0.67 (0.39-3.99) vs. 2.63 ± 1.06 (0.83-4.92) g/dL, respectively (p < 0.001). There was a statistically significant higher need for postoperative iron perfusion in the "LM" group, specifically 0 vs. 12 patients (p < 0.001), and lower postoperative anemia in "LM + TOHA" group (p < 0.001). Necessary artery clipping time was 10.62 ± 2.47 (7-15) minutes, with no significant impact on overall operative time: 110.2 ± 13.65 vs. 106.3 ± 16.48 (p = 0.21). There was no difference in the length of hospitalization or 12-month post-intervention fertility. DISCUSSION Performing bilateral TOHA prior to laparoscopic myomectomy has proven to be a valuable technique in reducing surgery-associated blood loss, while minimizing complications during surgery, with no significant increase in the overall operative time. CLINICAL TRIAL REGISTRATION ISRCTN registry, (www.isrctn.com), identifier ISRCTN66897343.
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10.
The Efficiency of a Uterine Isthmus Tourniquet in Minimizing Blood Loss during a Myomectomy-A Prospective Study
Balulescu, L., Brasoveanu, S., Pirtea, M., Balint, O., Ilian, A., Grigoras, D., Olaru, F., Margan, M. M., Alexandru, A., Pirtea, L.
Medicina (Kaunas, Lithuania). 2023;59(11)
Abstract
Background and Objectives: The objective of this study was to assess the effectiveness of using a peri-cervical tourniquet in reducing blood loss during a laparoscopic myomectomy. Materials and Methods: This prospective study evaluated the impact of performing a concomitant tourniquet placement during a laparoscopic myomectomy (LM). A total of 60 patients were randomly allocated to one of two groups: 30 patients who underwent an LM with a tourniquet placement (the TLM group) and 30 patients who benefited from a standard LM (the SLM group). This study's main objective was to evaluate the impact of tourniquet use on perioperative blood loss, which is quantified as the difference in the pre- and postoperative hemoglobin levels (Delta Hb) and the postoperative blood transfusion rate. Results: The mean Delta Hb was statistically lower in the TLM group compared to the SLM group: 1.38 g/dL vs. 2.41 g/dL (p < 0.001). The rate of postoperative iron perfusion in the TLM group was significantly lower compared to the SLM group (4 vs. 13 patients; p = 0.02). All four patients that required a blood transfusion were from the SLM group. On average, the peri-cervical tourniquet fastening time was 10.62 min (between 7 and 15 min), with no significant impact on the overall operative time: 98.50 min for the TLM group compared to 94.66 min for the SLM group. Conclusions: Fastening a tourniquet during a laparoscopic myomectomy is a valuable technique to effectively control intraoperative bleeding and enhance surgical outcomes.