Abstract

INTRODUCTION bleeding during and after caesarean section is one of the contributors to maternal mortality and morbidity. Tranexamic acid can be given before surgery to significantly reduce the amount of blood loss during caesarean section. The objective was to evaluate the effectiveness of preoperative tranexamic acid in reducing blood loss during caesarean section at Aminu Kano Teaching Hospital, Kano. METHODS this was a randomized double blind placebo controlled study that was carried out among 244 women who were to have emergency caesarean section between December 2017 and June 2018 and were randomly assigned to the study group or control group. Women in the study group received lg (10mls) of tranexamic acid intravenously while women in the control group received 10ml of normal saline. Oxytocin was administered in the two groups according to protocol. Measurement of blood loss was done immediately after surgery. Postoperative drop in haemoglobin and haematocrit were also determined. Statistical analysis was done using SPSS Version 22. RESULTS the average intra operative blood loss was 414.0 ml in the study group and 773.8 ml in the control group (t = - 16.18, p ≤ 0.01). Average postoperative haemoglobin was 10.1 g/dl in the study group and 9.5 g/dl in the control group (t = 4.99, p ≤ 0.01). Average postoperative haematocrit was 31.5% in the study group and 29.9% in the control group (t = 4.70, p ≤ 0.01). CONCLUSION there was a significant reduction in the blood loss when preoperative tranexamic acid was given to patients who were to undergo emergency caesarean section.

Abstract

BACKGROUND Strategies to preserve ovarian function after ovarian endometriotic cyst removal have been reported in many studies; however, no study has evaluated tranexamic acid administration during surgery. OBJECTIVE To evaluate feasibility of conducting a definitive trial and assessing the potential efficacy of tranexamic acid on ovarian reserve and intra-operative blood loss by comparing mean differences in anti-Müllerian hormone (AMH) levels following laparoscopic ovarian cystectomy between tranexamic acid and control groups. MATERIALS AND METHODS A parallel two-arm pilot trial was conducted with 40 participants with endometriotic cysts who underwent laparoscopic ovarian cystectomy. They were randomized 1:1 to either 1 g tranexamic acid (TXA) or no TXA (n = 20 per group). TXA was administered to the participants immediately after induction of general anesthesia and intubation. The primary outcome was the feasibility of conducting a definitive trial in terms of design and procedures (such as recruitment rate, retention, safety of intravenous 1 gm of TXA, sample size verification) and assess the efficacy of TXA on the ovarian reserve and intra-operative blood loss by comparing mean difference of AMH levels between TXA and control groups at pre- and 3 months post-surgery. RESULTS The recruitment and successful completion rates were 95% and 100%. Baseline characteristics were similar in the two groups. The mean difference of serum AMH levels (pre- and 3 months post-surgery) between the TXA and control groups was not significantly different. When performing a subgroup analysis, the mean difference of AMH levels (pre- and 3 months post-surgery) seemed to be higher in the bilateral than in the unilateral ovarian cyst group but not significantly different. Operating time was significantly longer in bilateral than in unilateral cysts. No post-operative complications or adverse effects were found. CONCLUSION The full randomized controlled trial for evaluating effects of TXA administration during laparoscopic cystectomy for endometrioma on ovarian reserve was shown to be feasible. Several modifications should be added for improving feasibility, for example, increasing the TXA dose, modifying TXA administration, focusing on either patients with unilateral or bilateral ovarian cysts, and exploring other outcome measures, e.g., surgeons' satisfaction. TRIAL REGISTRATION Thai Clinical Trials Registry, TCTR20190424002 , Registered 24 April 2019.

Abstract

INTRODUCTION Tranexamic acid is used as a known treatment of post-partum hemorrhage both in natural vaginal deliveries and cesarean sections, but its use in elective cesarean as a prophylactic measure to decrease the blood loss is not so common. OBJECTIVE This clinical trial evaluates the efficacy and safety of tranexamic acid in decreasing the bleeding in women undergoing elective cesarean section. METHOD 200 term singleton pregnant women who were scheduled for elective cesarean section were randomized to 2 groups and received a bolus of 1 gm tranexamic acid if body weight was <90 kg and 1.5 g if body weight was >90 kg diluted in 15 ml of 5% dextrose intravenously, or 5 ml of distilled water in 15 ml of 5% dextrose as placebo (before skin incision). Intra-operative and post-operative blood loss and hemoglobin levels were compared. RESULTS Tranexamic acid decreased the mean blood loss by 25.3 % in our studied women. Mean volume of intra-operative blood loss was 391.1 (±67.4) ml in tranexamic acid group and 523.8 (±153.4) ml in control group which was statistically significant lesser with a 132.7 ml difference. Rate of >1000 ml and >500 ml bleeding and need to blood transfusion were also statistically significant lower in tranexamic acid group., mean hemoglobin level was statistically significant lower in placebo group than tranexamic acid group (11.77 ± 0.50 versus 11.31 ± 0.56) 6 h after cesarean section. No adverse reaction was documented. CONCLUSION Prophylactic use of intravenous tranexamic acid decreases the blood loss safely in women undergoing elective cesarean section.

Abstract

OBJECTIVE To assess the efficacy and safety of prophylactic tranexamic acid administration in comparison with standard uterotonic agents alone among women undergoing cesarean delivery. DATA SOURCES Medline, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov and Google Scholar were systematically searched from inception to June 30, 2021. STUDY ELIGIBILITY CRITERIA Randomized controlled trials comparing intravenous tranexamic acid administration to placebo in women undergoing cesarean delivery and receiving standard prophylactic uterotonic agents were held eligible. STUDY APPRAISAL AND SYNTHESIS METHODS The risk of bias of individual studies was appraised with the RoB-2 tool. Meta-analysis was conducted by fitting random-effects models using restricted maximum likelihood. Subgroup analysis was performed based on country, protocol availability, double-blinding, risk of bias, sample size and tranexamic acid dose. One-stage meta-analysis was performed as a sensitivity analysis. The credibility of outcomes was appraised with the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS Overall, 36 studies with 10,659 women were included. Tranexamic acid administration was associated with significantly lower total blood loss (Mean difference-MD: -189.44 ml, 95% confidence intervals-CI: -218.63; -160.25), lower hemoglobin drop (MD: 8.22%, 95% CI: 5.54; 10.90), decreased risk of blood loss >1000 ml (Odds ratio-OR: 0.37, 95% CI: 0.22; 0.60), transfusion requirement (OR: 0.41, 95% CI: 0.26; 0.65) and need of additional uterotonics (OR: 0.36, 95% CI: 0.25; 0.52). Subgroup analysis indicated a greater effect of tranexamic acid on total blood loss reduction in low-middle income countries. The outcomes remained stable by separately evaluating women at low bleeding risk. One-stage meta-analysis demonstrated similar outcomes with the primary analysis. The quality of evidence was judged to be moderate regarding total blood loss and hemoglobin percentage change and low for the other outcomes. CONCLUSIONS This meta-analysis suggests that prophylactic tranexamic acid administration is effective among women undergoing cesarean delivery in lowering postpartum blood loss and limiting hemoglobin drop. Further research is needed to test its efficacy in high-risk populations and to verify its safety profile.

Abstract

BACKGROUND Bleeding is the leading cause of maternal mortality in the world. Tranexamic acid reduces bleeding in trauma and surgery. Several systematic reviews of randomized trials have investigated tranexamic acid in the prevention of bleeding in caesarean delivery. However, the conclusions from systematic reviews are conflicting. This overview aims to summarize the evidence and explore the reasons for conflicting conclusions across the systematic reviews. METHODS A comprehensive literature search of Medline, Embase, and Cochrane Database of Systematic Reviews was conducted from inception to April 2021. Screening, data extraction, and quality assessments were performed by two independent reviewers. A Measurement Tool to Assess Reviews 2 and the Risk of Bias Assessment Tool for Systematic Reviews were used for study appraisal. A qualitative synthesis of evidence is presented. RESULTS Fourteen systematic reviews were included in our analysis. Across these reviews, there were 32 relevant randomized trials. A modest reduction in blood transfusions and bleeding outcomes was found by most systematic reviews. Overall confidence in results varied from low to critically low. All of the included systematic reviews were at high risk of bias. Quality of evidence from randomized trials was uncertain. CONCLUSIONS Systematic reviews investigating prophylactic tranexamic acid in caesarean delivery are heterogeneous in terms of methodological and reporting quality. Tranexamic acid may reduce blood transfusion and bleeding outcomes, but rigorous well-designed research is needed due to the limitations of the included studies. Data on safety and adverse effects is insufficient to draw conclusions.

Abstract

BACKGROUND Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).

Abstract

BACKGROUND Myomectomy is associated with a significant risk of hemorrhage. Tranexamic acid is a synthetic lysine derivative with antifibrinolytic activity used in other surgical disciplines to reduce blood loss during surgery. However, its utility in gynecologic surgery is not well understood. OBJECTIVE To determine the effect of the early administration of intravenous tranexamic acid on perioperative bleeding and blood transfusion requirements in women undergoing a myomectomy. STUDY DESIGN Double-blinded randomized placebo controlled trial in an academic teaching hospital. Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss based on the following criteria were included in the study: 1) at least one fibroid greater than or equal to 10 cm, 2) any intramural or broad ligament fibroid greater than or equal to 6 cm, or 3) at least 5 total fibroids based on preoperative imaging. Patients were randomized to receive a single intravenous bolus injection of tranexamic 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes prior to initial surgical incision. Perioperative bleeding was defined by measuring intraoperative estimated blood loss, change between pre- and post-operative hemoglobin, and frequency of blood transfusions. Estimated blood loss was calculated by combining blood volume collected within the suction canister and weight of used sponges. The two groups were compared for age, body mass index, perioperative hemoglobin and hematocrit, perioperative blood loss, duration of surgery, blood transfusion requirements, and the number, total weight and volume of myomas removed. RESULTS Sixty patients (30 per arm) were enrolled into the study between March 1, 2015 and January 29, 2018. Age, body mass index, baseline hemoglobin/hematocrit, number and total weight of myomas removed, and largest myoma diameter did not differ between arms. Fifty-three percent (32/60) of the procedures were completed laparoscopically, 40% (24/60) robotically, and 7% (4/60) via laparotomy. Median estimated blood loss was 200 ml for the tranexamic acid group compared to 240 ml for the placebo group (p=0.88). There was no difference in median duration of surgery (165 versus 164 minutes; p=0.64) or change in perioperative hemoglobin (1.00 versus 1.1 g/dL; p=0.64). Patients who were administered tranexamic acid required no blood transfusions, compared to 4 patients (13.3%) in the placebo group (p=0.11). CONCLUSION Intravenous administration of tranexamic acid in patients undergoing mostly laparoscopic or robotic myomectomies was not associated with decreased blood loss.

Abstract

OBJECTIVES To determine the efficacy of tranexamic acid in decreasing blood loss in elective/emergency LSCS. MATERIALS AND METHODS A prospective randomised case control study was done in 200 pregnant women undergoing elective/emergency LSCS in the Department of Obstetrics and Gynaecology, at a tertiary care teaching hospital in Mysuru, from December 2018 to September 2019. Women in the age group of 18-35 years were included in the study. Those with anaemia (Hb < 10 gm%), hypertension in pregnancy, bleeding diathesis, GDM on insulin, polyhydramnios, oligohydramnios, cardiac and chronic liver disorders were excluded from the study. Two hundred women undergoing emergency/elective LSCS were divided into case (group 1) or control (group 2) groups using a computer-generated random number table. Tranexamic acid (10 mg/Kg) was given in 100 ml Normal Saline 10 mins prior to skin incision to women in the first group, along with routine care (10 Units of Oxytocin IM soon after extraction of the baby). Routine care, as per institutional protocol, was followed in the second group. The primary outcome was to estimate the intraoperative blood loss. Blood loss was measured by weighing pads, mops, drapes before and after surgery and blood in the suction container after surgery. Two separate suction catheters and containers were used, in order to minimise mixing of blood and amniotic fluid. Total blood loss was calculated as the difference in the weight of the pads, mops and drapes before and after surgery and the sum of the amount of blood in suction container. The difference between the pre-operative and post-operative haemoglobin and haematocrit was compared. The pre-operative, intra-operative and post-operative hemodynamics were also compared. RESULTS Statistical analysis was done using MS Excel and R-3.5.1 software. Unpaired and paired t test were used. In our study, there was a significant decrease in intraoperative bleeding in women receiving tranexamic acid. Women in the control group had a significant fall in the postoperative hemoglobin when compared to women who received tranexamic acid. Also, women who received tranexamic acid did not develop any significant hemodynamic changes during or immediately after the surgery. CONCLUSION Tranexamic acid can be safely used as a prophylactic agent to reduce bleeding during elective and emergency LSCS.

Abstract

AIM: Tranexamic acid (TXA) has been used to treat peripartum hemorrhage, while preoperative use of TXA in cesarean section (CS) remains controversial. To assess the effectiveness and safety of prophylactic application of TXA, a meta-analysis was performed. METHODS Electronic databases (MEDLINE [PubMed], Cochrane central register of controlled trials and Embase) were searched up to November 2018. The relevant data and quality of included trail were analyzed by RevMan 5.3. The study was registered at PROSPERO (CRD42018111165). RESULTS Twenty-one randomized controlled trials with a total of 3852 patients were included. Only one research reported thromboembolic events. Compared with control groups, the intra-operative blood loss (mean difference [MD] -155.23 mL, 95% confidence interval [CI] -195.64 - 114.81; P<0.01), postoperative blood loss (MD -26.67 mL, 95% CI -32.98 to -20.36; P<0.01), total blood loss (MD -184.88 mL, 95% CI -218.83 to -150.94; P<0.01), transfusion requirements (relative risk [RR] 0.29, 95% CI 0.18-0.49, P<0.01), massive hemorrhage (RR 0.39, 95% CI 0.30 to 0.51; P<0.01) and additional uterotonic agents use (RR 0.40, 95% CI 0.30-0.55, P<0.01) were markedly reduced in TXA-treated patients. Besides, TXA yielded a significant reduction in hemoglobin drop (MD -0.80 g/dL, 95% CI -1.07 to -0.53; P<0.01) and hematocrit drop (MD -2.05, 95% CI -3.09 to -1.01; P<0.01) compared with control groups. CONCLUSION Prophylactic application of TXA can decrease perioperative blood loss and transfusion requirements in patients undergoing CS. More high-quality researches are needed to determine optimal dose of the drug.

Abstract

BACKGROUND Uterine fibroids are the commonest tumour of the female genital tract; about one third are symptomatic and require management. The treatment of uterine fibroids may be medical, surgical, conservative or expectant. Myomectomy is the common surgical treatment option for women failing medical management and desiring to preserve fertility and/or their uterus. The tourniquet is shown to be effective in reducing blood loss during myomectomy and tranexamic to a less extent. However, the adjunctive use of tranexamic acid with tourniquet to further reduce blood loss has not been studied. AIM: The aim of the study was to determine the efficacy of perioperative intravenous tranexamic acid in further reducing blood loss at abdominal myomectomy when used as an adjunct to tourniquet. METHODS The study was a randomized double-blind controlled study involving women who underwent abdominal myomectomy. Participants were randomized to either tourniquet plus intravenous tranexamic acid or tourniquet plus placebo groups using simple random sampling. The primary outcomes were the intra-operative blood loss, post-operative haematocrit values and need for intra-operative blood transfusion. The data was analyzed using the SPSS software version 23.0 and p value<0.05 was significant. RESULTS The mean intra-operative blood loss (998.72+/-607.21ml vs 907.25+/-529.85ml, p=0.475), intra-operative blood transfusion rate (45% vs. 30%; p=0.166) and mean unit of blood transfused (1.13+/-1.64 vs. 0.75+/-1.28; p=0.256) were higher for tourniquet plus placebo group compared to tourniquet plus tranexamic acid group. The estimated blood loss per 100g of fibroid removed was reduced significantly in the tranexamic acid plus tourniquet group (139.80+/-2.28ml vs 104.09+/-1.97ml; p=0.001). STRENGTH AND LIMITATIONS The strength of the study include randomization and blinding. The limitations included non-uniformity of sizes and locations of fibroids, as well as the different surgeons with possibly different skills, techniques and experiences, though they were statistically not significant. CONCLUSION The adjunctive use of tranexamic acid to tourniquet significantly further reduces intraoperative blood loss during abdominal myomectomy when compared to tourniquet alone. RECOMMENDATIONS Adjunctive use of tranexamic acid is recommended for further reducing intra-operative blood loss during abdominal myomectomy.