Prophylactic tranexamic acid during myomectomy: A systematic review and meta-analysis of randomized controlled trials
European journal of obstetrics, gynecology, and reproductive biology. 2022;276:82-91
OBJECTIVE To conduct a systematic review and meta-analysis of randomized controlled trials on the clinical efficacy and safety of prophylactic tranexamic acid (TXA) versus control (normal saline/no treatment) during myomectomy. METHODS Six databases were screened from inception until 21-February-2022. The eligible studies were assessed for risk of bias. The outcomes were summarized as mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) in a random-effects model. RESULTS Seven studies, comprising eight arms and 571 patients (TXA = 304 patients, control = 267 patients) were analyzed. The included studies had an overall low risk of bias. The mean intraoperative blood loss (MD = -224.34 ml, 95% CI [-303.06, -145.61], p < 0.001), mean postoperative blood loss, and mean total blood loss were significantly reduced in favor of the prophylactic TXA group. Additionally, the mean postoperative hemoglobin (MD = 0.4 mg/dl, 95% CI [0.11, 0.68], p = 0.006) and mean postoperative hematocrit levels were significantly higher in favor of the prophylactic TXA group. While the mean hospital stay was significantly reduced in favor of the prophylactic TXA group (MD = -0.39 d, 95% [-0.74, -0.04], p = 0.03), there was no significant difference between both groups regarding the mean operation time and rate of blood transfusion. None of the participants in both groups developed any incidence of thromboembolic events. The rate of nausea was significantly higher in disfavor of the prophylactic TXA group (RR = 2.68, 95% CI [1.11, 6.43], p = 0.03). CONCLUSION Among patients undergoing myomectomy, prophylactic TXA was largely safe and linked to substantial reductions in perioperative blood loss and related morbidities.
Intraoperative Cell Salvage for Women at High Risk of Postpartum Hemorrhage During Cesarean Section: a Systematic Review and Meta-analysis
Reproductive sciences (Thousand Oaks, Calif.). 2022
Postpartum hemorrhage (PPH) can lead to substantial blood loss that compromises maternal hemodynamic stability and consequently cause severe maternal complications such as organ dysfunction or death. Intraoperative cell salvage (IOCS), an effective method of blood conservation used in other surgical specialties, can be an alternative intervention for managing PPH. Thus, our aim was to evaluate the efficacy and safety of IOCS for women at high risk of PPH undergoing cesarean sections. We conducted a systematic search of electronic databases from inception to February 25, 2021 for randomized controlled studies and observational studies published in English or Mandarin about IOCS use in cesarean sections. Primary outcomes of interest were changes in postoperative hematologic parameters and any adverse events reported among patients that had IOCS and controls that had an allogeneic blood transfusion. The certainty of the evidence of the outcomes was evaluated using the GRADE approach. A total of 24 studies with 5872 patients were included in the meta-analysis. Eleven randomized controlled trials (RCTs), and 13 observational studies were analyzed. Postoperative hemoglobin levels were higher among patients with IOCS SMD 0.39 (95% CI; 0.20, 0.60; P < 0.001, high certainty). Allogeneic blood transfusion increased adverse events RR = 1.81(95% CI; 1.24, 2.62; P = 0.002, low certainty). IOCS shortened hospital stay SMD - 0.59 (95% CI: - 0.98, - 0.19; P = 0.004, low certainty) and shortened prothrombin time SMD - 0.67 (95% CI; - 1.31, - 0.04), P = 0.037, low certainty). The lower incidence of transfusion-related adverse events and shorter hospital stay among other findings demonstrate that IOCS use in obstetrics is an effective and safe alternative for the management of PPH; however, high-quality randomized control studies are required to confirm this evidence.
The Effect of Intravenous Tranexamic Acid on Myomectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Journal of personalized medicine. 2022;12(9)
Myomectomy is the preferred surgical treatment for symptomatic women with uterine myomas who wish to preserve their fertility. The procedure may be associated with significant intraoperative blood loss, which predisposes to increased transfusion rates and morbidity. The objective of our systematic review and meta-analysis is to investigate whether intravenous (IV) use of tranexamic acid (TXA) may reduce blood loss during myomectomy. Three electronic databases were screened until June 2022. The eligible studies were assessed for risk of bias. Four randomized controlled trials that reported outcomes from a total of 310 women were finally included in the meta-analysis-155 patients received intravenous TXA while the remaining 155 received placebo injection with normal saline or water for injection. Total estimated blood loss was significantly lower in patients who received TXA before myomectomy compared to control (230 patients MD -227.09 mL 95% CI -426.26, -27.91, p = 0.03). This difference in favor of TXA group remained when intraoperative and postoperative blood loss was separately analyzed. Postoperative hematocrit values and hemoglobin levels did not differ among the two groups (180 patients MD 0.67% 95% CI -0.26, 1.59, p = 0.16 and 250 patients MD 0.17 mg/dL 95% CI 0.07, 0.41, p = 0.17, respectively). The number of patients that received blood transfusion was also not different (310 patients OR 0.46 95% CI -0.14, 1.49, p = 0.19). Total operative time was significantly prolonged in control group compared to TXA (310 patients MD -16.39 min 95% CI -31.44, -1.34 p = 0.03). Our data show that the IV use of TXA may significantly reduce intraoperative blood loss in patients undergoing myomectomy and contribute to reduced operative time.
Impact of "natural" cesarean delivery on peripartum blood loss: A randomized controlled trial
American journal of obstetrics & gynecology MFM. 2022;:100642
BACKGROUND Early skin to skin contact after vaginal delivery increases milk production and may increase oxytocin release, leading to reduction in postpartum hemorrhage (PPH) rate. OBJECTIVE To examine the impact of "natural" cesarean deliveries (NCD) on perioperative maternal blood loss. STUDY DESIGN This is a randomized controlled trial conducted at a single university affiliated medical center, between August 2016 and February 2018. Term singleton gestations scheduled for a planned CD under spinal anesthesia were included. Women were randomized at a ratio of 1:1 to NCD (study group) or traditional CD (control group) during the routine preoperative assessment. Women in the study group watched fetal extraction, had early skin to skin contact, and breastfed until the end of surgery. Neonates in the control group were presented to the mother for few minutes. Blood samples were drawn from all women, during fascia closure, to determine oxytocin levels using an ELISA kit. The Laboratory component was performed after recruitment completion and was accomplished in February 2019. The primary outcome was postpartum hemoglobin (Hb) levels. To detect a difference of 0.5 g/dL between the groups with α = .05 and β = 80%, 214 women were needed. RESULTS Of 214 women that were randomized, 23 were excluded. There were no significant differences in demographic and obstetric variables between the groups. Postpartum Hb levels were 10.1±1.1 and 10.3±1.3 g/dL in the study and control groups, respectively (P = .19). There were no significant differences in rates of PPH and blood transfusion. Maternal pain scores, satisfaction, and exclusive breastfeeding, were comparable. Maternal oxytocin blood levels were 389.5±183.7 and 408.5±233.6 pg/mL in the study and control groups, respectively (P = .96). Incidence of neonatal hypothermia was comparable between the groups (P=.13). CONCLUSIONS NCD does not affect perioperative Hb level or maternal oxytocin blood concentration. CLINICAL TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02768142.
Impact of Hemostatic Approach after Laparoscopic Endometrioma Excision on Ovarian Reserve: Systematic Review and Network Meta-Analysis of Randomized Controlled Trials
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2022
BACKGROUND Laparoscopic excision of endometrioma and subsequent hemostasis have detrimental effects on ovarian reserve. OBJECTIVES To evaluate which hemostatic approach after stripping cystectomy shows less damage on ovarian reserve. SEARCH STRATEGY EMBASE, MEDLINE, Scopus, Scielo.br, LILACS, Cochrane at Central, Clinicaltrials.gov, CINAHL, conference abstracts and international controlled trials registry were searched from inception until April 2022. SELECTION CRITERIA Randomized controlled trials (RCTs) of women undergoing laparoscopic endometrioma excision that compared at least two hemostatic approaches. DATA COLLECTION AND ANALYSIS Relevant data were extracted and tabulated. Network meta-analysis based on random effects model for mixed multiple treatment to rank hemostatic strategies using the surface under the cumulative ranking curve area (SUCRA) was performed. Quality assessment was performed using Cochrane criteria. Primary outcome was serum Antimullerian hormone (AMH) levels 3 months after surgery. MAIN RESULTS Ten studies, including 748 women, were selected. Suturing the ovary with barbed suture (SUCRA=82.80%) seem the most effective strategy to avoid AMH reduction. Similarly, for ultrasonographic antral follicular count, barbed (SUCRA=30.70%) and simple suture (SUCRA=30.70%) were ranked best choices. Ovarian suturing with simple suture demonstrated lower FSH levels (SUCRA=88.70%). CONCLUSIONS Suturing the ovary, with simple or barbed suture, seems the most effective approach to keep ovarian reserve higher.
Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery
The aim of this study was to evaluate the population pharmacokinetics of tranexamic acid (TXA) administered intravenously at a single dose of 0.5 or 1 g in parturients undergoing active hemorrhagic cesarean delivery and to evaluate the influence of patient variables on TXA pharmacokinetics. Subjects from three recruiting centers were included in this PK sub-study if randomized in the experimental group (i.v TXA 0.5 g or 1 g over one minute) of the TRACES study. Blood samples and two urinary samples were collected within 6 h after TXA injection. Parametric non-linear mixed-effect modeling (Monolix v2020R1) was computed. The final covariate model building used 315 blood and 117 urinary concentrations from seventy-nine patients. A two-compartment model with a double first-order elimination from the central compartment best described the data. The population estimates of clearance (CL), central volume of distribution (V1), and half-life for a typical 70 kg patient with an estimated renal clearance of 150 mL/min (Cockroft-Gault) were 0.14 L/h, 9.25 L, and 1.8 h. A correlation between estimated creatinine clearance and CL, body weight before pregnancy, and V1 was found and partly explained the PK variability. The final model was internally validated using a 500-run bootstrap. The first population pharmacokinetic model of TXA in active hemorrhagic caesarean section was successfully developed and internally validated.
Effect of intravenous ascorbic acid administration on hemorrhage and wound complications in total abdominal hysterectomy: A prospective randomized clinical trial
Clinical nutrition ESPEN. 2022;49:74-78
OBJECTIVE Previous studies mentioned the beneficial effects of vitamin C on the hemorrhage and wound healing. We evaluated the effects of vitamin C on the hemorrhage, hemoglobin concentration, and wound complications in total abdominal hysterectomy. MATERIALS AND METHODS In this randomized, double-blind, placebo-controlled trial, 80 patients with total abdominal hysterectomy were randomly divided into the study and control groups to receive either intravenous 2 g of vitamin C in normal saline or solely normal saline therapy. The first 1-g dose of ascorbic acid was administrated the night before surgery, and the second 1 g was administrated during surgery. RESULTS The mean age of the participants was 37.8 ± 4.8 years with a mean preoperative plasma vitamin C concentration of 5.07 ± 2.1 mg/dL, close to the subclinical deficiency. The basal characteristics of both groups were the same. The hemorrhage volume was slightly higher in the control group (345.2 ± 31.8 ml vs. 388.1 ± 28.3 ml, P < 0.001). CONCLUSION Intravenous vitamin C administration had a positive effect on reducing hemorrhage during total abdominal hysterectomy. TRIAL REGISTRATION Clinicaltrials.gov.identifier: NCT03965637.
Value of intrauterine platelet-rich concentrates in patients with intrauterine adhesions after hysteroscopy: A systematic review and meta-analysis of randomized controlled trials
European journal of obstetrics, gynecology, and reproductive biology. 2022;271:63-70
OBJECTIVE To evaluate the value of intrauterine platelet-rich concentrates among patients with intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis. METHODS Four different databases (PubMed, Cochrane Library, Scopus, and ISI web of science) were searched for the available studies from inception to November 2021. We selected randomized clinical trials (RCTs) that compared platelet-rich concentrates in the intervention group versus no injection of platelet-rich concentrates in the control group among women with intrauterine adhesions after operative hysteroscopy. Revman software was utilized for performing our meta-analysis. Our primary outcomes were the adhesion score and incidence of recurrence of severe intrauterine adhesions postoperatively. Our secondary outcomes were the clinical pregnancy rate, menstrual flow duration in days, and menstrual flow amount (number of pads). RESULTS Five RCTs met our inclusion criteria with a total number of 329 patients. We found that platelet-rich concentrates were linked to a significant reduction in the postoperative adhesion score (MD = -1.00, 95% CI [-1.68, -0.32], p = 0.004). Moreover, there was a significant reduction in the incidence of severe IUAs recurrence among the platelet-rich concentrates group (7.6%) compared to the control group (23.4%) after hysteroscopy (p = 0.001). The clinical pregnancy rate was significantly increased among the platelet-rich concentrates group (37.1%) in comparison with the control group (20.7%) after hysteroscopic adhesiolysis (p = 0.008). There were significant improvements in the menstrual flow duration and amount among the platelet-rich concentrates group (p < 0.001). CONCLUSIONS Intrauterine placement of platelet-rich concentrates is an effective method for the treatment of intrauterine adhesions after hysteroscopy.
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.
Does immediate skin-to-skin contact at caesarean sections promote uterine contraction and recovery of the maternal blood haemoglobin levels? A randomized clinical trial
Nursing open. 2022
AIM: We analysed whether immediate skin-to-skin contact between the healthy newborn and the mother after a caesarean section has a modulatory role on postpartum haemorrhage and uterine contraction. DESIGN Unblinded, randomized clinical trial, simple random sampling, conducted in women undergoing caesarean sections. METHODS Of the population identified, the caesarean section total (N = 359), 23.2% (N = 83) met the inclusion criteria: scheduled caesarean section, accepting skin-to-skin contact, good level of consciousness. They were randomly allocated to the intervention group, skin-to-skin contact (N = 40), and to the control group, usual procedure (N = 40). There were three losses. Clinical variables: plasma haemoglobin, uterine contraction, breastfeeding, postoperative pain, were measured, and subjective variables: maternal satisfaction, comfort, comparison with previous caesarean section and newborn crying. RESULTS Women with skin-to-skin contact had greater uterine contraction after caesarean section. The maternal plasma haemoglobin levels at discharge were significantly higher. It was associated with higher breastfeeding rate, satisfaction, comfort levels and with less maternal pain and less crying in the newborn.