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1.
Efficacy and safety of tranexamic acid in prevention of postpartum hemorrhage: a systematic review and meta-analysis of 18,649 patients
Al-Dardery, N. M., Abdelwahab, O. A., Abouzid, M., Albakri, K., Elkhadragy, A., Katamesh, B. E., Hamamreh, R., Mohd, A. B., Abdelaziz, A., Khaity, A.
BMC pregnancy and childbirth. 2023;23(1):817
Abstract
BACKGROUND In this meta-analysis, we aimed to update the clinical evidence regarding the efficacy and safety of TXA in the prevention of PPH. METHODS A literature search of PubMed, Scopus, Web of Science, Google Scholar, and Cochrane Library from inception until December 2022 was conducted. We included randomized controlled trials (RCTs) comparing TXA with a placebo among pregnant women. All relevant outcomes, such as total blood loss, the occurrence of nausea and/or vomiting, and changes in hemoglobin, were combined as odds ratios (OR) or mean differences (MD) in the meta-analysis models using STATA 17 MP. RESULTS We included 59 RCTs (18,649 patients) in this meta-analysis. For cesarean birth, TXA was favored over the placebo in reducing total blood loss (MD= -2.11 mL, 95%CI [-3.09 to -1.14], P < 0.001), and occurrence of nausea or/and vomiting (OR = 1.36, 95%CI [1.07 to 1.74], P = 0.01). For vaginal birth, the prophylactic use of TXA was associated with lower total blood loss, and higher occurrence of nausea and/or vomiting (MD= -0.89 mL, 95%CI [-1.47 to -0.31], OR = 2.36, 95%CI [1.32 to 4.21], P = 0.02), respectively. However, there were no differences between the groups in changes in hemoglobin during vaginal birth (MD = 0.20 g/dl, 95%CI [-0.07 to 0.48], P = 0.15). The overall risk of bias among the included studies varies from low to high risk of bias using ROB-II tool for RCTs. CONCLUSIONS This meta-analysis suggested that TXA administration is effective among women undergoing cesarean birth or vaginal birth in lowering total blood loss and limiting the occurrence of PPH. Further clinical trials are recommended to test its efficacy on high-risk populations.
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2.
Shock index as a predictor of postpartum haemorrhage after vaginal delivery: Secondary analysis of a multicentre randomised controlled trial
Madar, H., Deneux-Tharaux, C., Sentilhes, L.
BJOG : an international journal of obstetrics and gynaecology. 2023
Abstract
OBJECTIVE To describe the shock index (SI) distribution during the first 2 hours after delivery and to evaluate its performance when measured 15 and 30 minutes after delivery for predicting postpartum haemorrhage (PPH) occurrence in the general population of parturients after vaginal delivery. DESIGN Secondary analysis of a multicentre randomised controlled trial testing prophylactic administration of tranexamic acid versus placebo in addition to prophylactic oxytocin to prevent PPH. SETTING 15 French maternity units in 2015-2016. SAMPLE 3891 women with a singleton live fetus ≥35 weeks, born vaginally. METHODS For each PPH-related predicted outcome, we calculated the area under the receiver operating characteristic curve (AUROC) values of the SI at 15 and 30 minutes after delivery and its predictive performance for SI cut-off values of 0.7, 0.9 and 1.1. MAIN OUTCOME MEASURES Quantitative blood loss ≥1000 ml (QBL ≥1000 ml) measured in a graduated collector bag and provider-assessed clinically significant PPH (cPPH). RESULTS Prevalence of QBL ≥1000 ml and cPPH was respectively 2.7% (104/3839) and 9.1% (354/3891). The distributions of the SI at 15 and 30 minutes after delivery were similar with a median value of 0.73 and 97th percentile of 1.11 for both. The AUROC values of the 15-minute SI for discriminating QBL ≥1000 ml and cPPH were respectively 0.66 (lower limit of the 95% confidence interval [LCI] 0.60) and 0.56 (LCI 0.52); and for the 30-minute SI 0.68 (LCI 0.61) and 0.49 (LCI 0.43). CONCLUSIONS The shock index at 15 and 30 minutes after delivery did not satisfactorily predict either QBL ≥1000 ml or clinical PPH.
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3.
To Study the Efficacy and Safety of Diosmin with Tranexamic Acid and Mefenamic Acid Versus only Tranexamic Acid and Mefenamic Acid in Medical Management of Abnormal Uterine Bleeding: A Randomized Controlled Trial
Sharma, J. B., Kumari, R., Kumari, S., Jain, S., Dharmendra, S.
Journal of mid-life health. 2023;14(2):87-93
Abstract
BACKGROUND Abnormal uterine bleeding (AUB) is a common problem in reproductive age group and perimenopausal age group being responsible for many outpatient visits. Traditional management of AUB consists of giving mefenamic acid, tranexamic acid, or their combination with progestogens or hormonal intrauterine deviced levonorgestrel intrauterine system (LNG-IUS) for severe or nonresponsive cases. The objective of the current study was to study the efficacy and safety of adding diosmin along with tranexamic acid and mefenamic acid in reducing menstrual blood loss in AUB patients. MATERIALS AND METHODS It was a prospective double-blind randomized controlled trial in which 900 mg of diosmin was given once daily along with 500 mg tranexamic acid and 250 mg mefenamic acid during menstruation (Group I-92 patients), or only tranexamic acid and mefenamic acid during menstruation (Group II-92 patients). RESULTS Mean age, parity, body mass index, and socioeconomic status were similar in the two groups. It was 35.68 years versus 36.78 years, 2.2 versus 2.3, 23.68 kg/m(2) versus 24.62 kg/m(2) respectively. Mean days of bleeding before this treatment were 6.8 versus 6.6 (P = 0.33) and were 3.5 versus 5.2 (P = 0.02) after treatment. There was a significant reduction in both groups as compared to before treatment (P = 0.021 in Group I, 0.027 in Group II) but the reduction was greater in Group I (P = 0.02). The amount of blood loss was 385 ml versus 390 ml (P = 0.7) before treatment which was significantly reduced in both groups to 68 ml versus 112 ml (P = 0.02 in Group I, 0.03 in Group II) with more decrease in Group I than in Group II (P = 0.01). Mean hemoglobin at beginning of the study was 8.4 versus 8.5 g/dl in Group I and Group II (P = 0.02) and significantly increased in both groups posttreatment to 10.9 and 9.8 g/dl in Group I and Group II (P = 0.012 in Group I, 0.011 in Group II) with increase being more in Group I than Group II (P = 0.03). Pictorial blood assessment chart score was 398 versus 406 (P = 0.35) before treatment and decreased significantly to 86.5 and 110.5 (P = 0.001 in Group I, 0.001 in Group II) with more decrease being in Group I than II (P = 0.01). There was significant decrease in dysmenorrhea with both treatments with no difference in the two groups. Various adverse effects such as nausea, vomiting, abdominal pain, diarrhea, constipation, and headache were equal in the two groups. CONCLUSION Both the group's diosmin with tranexamic acid and mefenamic acid (Group I) and tranexamic acid and mefenamic acid (Group II) were efficacious in reducing menstrual blood loss, number of menstrual days and dysmenorrhea with effect being more by addition of diosmin. Adverse effects were equal in both the two groups.
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4.
Tranexamic acid, as an adjunct to oxytocin prophylaxis, in the prevention of postpartum hemorrhage in women undergoing elective caesarean section: a single centre double-blind randomised controlled trial
Lee SH, Kwek ME, Tagore S, Wright A, Ku CW, Teong ACA, Tan AWM, Lim SWC, Yen DYT, Ang CYX, et al
BJOG : an international journal of obstetrics and gynaecology. 2023
Abstract
OBJECTIVE To evaluate the effectiveness of tranexamic acid (TXA) in reducing blood loss during elective caesarean sections in women with and without risk factors for PPH. DESIGN A double-blind, randomised placebo-controlled trial. SETTING An academic tertiary referral centre in Singapore. POPULATION Multiethnic women aged 21 years old and above undergoing elective caesarean section were randomised to receive intravenous TXA or placebo 10 minutes before skin incision. MAIN OUTCOME MEASURES Calculated estimated blood loss (cEBL), derived from blood volume and hematocrit levels. RESULTS Between June 2020 and October 2021, 200 women were randomised into the placebo or TXA groups. Women who received prophylactic TXA had a significantly lower mean cEBL compared with those receiving placebo (adjusted mean difference -126.4 ml, 95% CI -243.7 to -9.1, p=0.035). Effect was greatest in those at high risk for PPH, with reduction in cEBL (mean difference -279.6 ml, 95% CI -454.8 to -104.3, p=0.002), and lower risk of cEBL ≥ 500 ml (RR 0.54, 95% CI 0.36 to 0.83, p=0.007) and cEBL ≥ 1000 ml (RR 0.44, 95% CI 0.20 to 0.98, p=0.016). Subgroup analysis showed benefit for women with preoperative haemoglobin < 10.5 g/dL (mean difference -281.9 ml, 95% CI -515.0 to -48.8, p=0.019). There was no significant difference in need for additional medical or surgical interventions. There were no maternal or neonatal adverse outcomes. CONCLUSION Prophylactic TXA should be considered in women with risk factors for PPH, and those most likely to benefit are those with pre-operative haemoglobin <10.5 g/dL.
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5.
Intravenous tranexamic acid vs. sublingual misoprostol in high-risk women for postpartum haemorrhage following cesarean delivery; a randomised clinical trial
Dawoud, M., Al-Husseiny, M., Helal, O., Elsherbini, M., Abdel-Rasheed, M., Sediek, M.
BMC pregnancy and childbirth. 2023;23(1):611
Abstract
OBJECTIVE This study compares the effectiveness of administering sublingual misoprostol combined with oxytocin to that of IV tranexamic acid combined with oxytocin to reduce intra and post-operative blood loss in high-risk women for postpartum haemorrhage (PPH) following cesarean section (CS). METHODS About 315 high-risk pregnant women undergoing CS participated in this trial. They were randomly assigned into three groups; tranexamic group, misoprostol group, and control group, according to the medication given in the operative theatre. All patients received oxytocin intraoperatively. They were assessed regarding intraoperative blood loss, the incidence of PPH, and the reduction in haemoglobin and hematocrit values. RESULTS Both tranexamic and misoprostol groups had similar results in reducing intra and post-operative blood loss. However, the reduction in haemoglobin and hematocrit were significantly lower in tranexamic and misoprostol groups compared to the control group (-0.78 ± 0.57 vs. -0.83 ± 0.52 vs. -1.32 ± 0.57 gm/dl, P < 0.001 and - 3.05 ± 1.28 vs. -3.06 ± 1.13 vs. -4.94 ± 1.82%, P < 0.001 respectively). In addition, the estimated blood loss was significantly lower in the tranexamic and misoprostol groups compared to the control group (641.6 ± 271.9 vs. 617.9 ± 207.4 vs. 1002.4 ± 340.7 ml, P < 0.001). CONCLUSION Both tranexamic acid and misoprostol are equally capable of reducing blood loss, but the results were significantly better compared to using oxytocin alone in high-risk patients. CLINICAL TRIAL REGISTRATION Registered at www. CLINICALTRIALS govon07/10/2019 with registration number NCT04117243.
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6.
Use of tranexamic acid (TXA) to reduce preterm birth and other adverse obstetrical outcomes among pregnant individuals with placenta previa: a systematic review protocol
Seguin, N., Visintini, S., Muldoon, K. A., Walker, M.
BMJ open. 2023;13(3):e068892
Abstract
INTRODUCTION Placenta previa is a placental implantation pathology where the placenta overlies the internal endocervical os. Placenta previa affects approximately 4 per 1000 pregnancies and increases the risk of antepartum bleeding, emergent preterm labour and emergency caesarean sections. Currently, placenta previa is managed through expectant management. Guidelines primarily revolve around the mode and timing of delivery, in-hospital admissions and surveillance. However, the methods to prolong pregnancy have not proven to be clinically effective. Tranexamic acid (TXA), an antifibrinolytic agent, is effectively used to prevent and treat postpartum haemorrhage as well as menorrhagia, with limited adverse effect, and may prove to be an effective treatment for placenta previa. The objective of this systematic review protocol is to review and synthesise the evidence of TXA use for antepartum haemorrhage in placenta previa. METHODS AND ANALYSIS Preliminary searches were conducted on 12 July 2022. We will search MEDLINE, EMBASE, CINAHL, Scopus and the Cochrane Central Register of Controlled Trials. Grey literature resources such as clinical trials registries (ClinicalTrials.gov and the WHO's International Clinical Trials Registry) and preprint servers (Europe PMC and Open Science Framework) will also be searched. The search terms will comprise of index headings and keyword searches related to TXA and the placenta or antepartum bleeding. Cohort and randomised and non-randomised trials will be considered. The target population is pregnant people, of any age, with placenta previa. The intervention is TXA given in the antepartum period. The main outcome of interest is preterm birth before 37 weeks, however, all perinatal outcomes will be collected. Title and abstract will be screened by two reviewers and any conflict will be discussed and evaluated by a third reviewer. The literature will be summarised in narrative form. ETHICS AND DISSEMINATION No ethics approval is required for this protocol. Findings will be disseminated through peer-review publication, lay summaries and conference presentations. PROSPERO REGISTRATION NUMBER CRD42022363009).
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7.
Tranexamic acid for the prevention of postpartum haemorrhage: the TAPPH-1 pilot randomized trial and lessons learned for trials in Canadian obstetrics
Alam, A. Q., Barrett, J., Callum, J., Kaustov, L., Au, S., Fleet, A., Kiss, A., Choi, S.
Scientific Reports. 2023;13(1):4512
Abstract
Postpartum haemorrhage (PPH) is a leading cause of maternal morbidity and mortality. While tranexamic acid (TXA) reduces bleeding and transfusion requirements in established PPH, we sought to determine the feasibility of conducting a fully powered trial assessing the effect of prophylactic tranexamic acid, prior to PPH onset, in a Canadian Obstetric setting. With institutional and Health Canada approval, consenting, eligible parturients (singleton, > 32 weeks gestation, vaginal or caesarian delivery) were randomly assigned to receive TXA (1 g intravenously) or placebo (0.9% saline) prior to delivery. Participants, investigators, data collectors/adjudicators, and analysis was blinded. The primary outcome was administration of study intervention to > 85% of randomized individuals. Secondary outcomes included recruitment rate (feasibility) and safety outcomes. Over 8 months, 611 were approached, 35 consented, and 27 randomized (14 TXA, 13 placebo). 89% of randomized participants received the assigned intervention. Recruitment fell below feasibility (23% target). No serious adverse outcomes occurred. Our pilot trial in a Canadian Obstetric setting was unable to demonstrate feasibility to conduct a large, multicentre trial to examine prophylactic use of tranexamic for PPH secondary to the complex regulatory requirements associated with a trial for an off-label, but commonly utilized intervention. These challenges should inform stakeholders on the resources and challenges of conducting future trials using off-label interventions.Trial registration: www.clinicaltrials.gov , NCT03069859 (03/03/2017).
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8.
The effect of pre-operative intravenous tranexamic acid versus rectal misoprostol in reducing blood loss during and after elective cesarean section in primigravida: A double-blinded, randomized, comparative-placebo trial
Afifi, A. N., Taymour, M. A., Mahmoud, S. I., Zolfokar, D. S., Moghazy Salman, M. S., El-Hafeez Abd El-Latif, A. A., El-Khayat, W. M.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC. 2023;:102264
Abstract
OBJECTIVE To compare the effectiveness of preoperative intravenous tranexamic acid and rectal misoprostol in reducing post-cesarean section blood loss. METHODS In the randomized controlled trial, two groups were formed from 200 pregnant women undergoing elective cesarean sections. The tranexamic acid group received a 1 g intravenous injection of tranexamic acid 10 minutes before skin incision, whereas the misoprostol group received 800 mcg of rectal misoprostol preoperatively. Both groups received 20 units of oxytocin in a 500 ml ringer lactate intravenous infusion at a rate of 125 ml/h after delivery. Blood loss was assessed by measuring the number of gauzes used, the amount of blood in the suction container, and changes in hemoglobin and hematocrit levels before and after surgery. RESULTS Blood loss in tranexamic acid was 906.36 ± 75.34 vs. 778.01 ± 94.96 ml in the misoprostol group (P < 0.0001) and change in hemoglobin and hematocrit was less in the misoprostol group (P < 0.0001). CONCLUSION Misoprostol is more effective than tranexamic acid in reducing blood loss during and after cesarean sections.
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9.
Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial
Igboke FN, Obi VO, Dimejesi BI, Lawani LO
BMC pregnancy and childbirth. 2022;22(1):178
Abstract
BACKGROUND Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide. Tranexamic acid (TXA) is a useful drug for prevention of PPH and merits evaluation in Nigeria, where PPH is the leading cause of maternal death (25%) and severe maternal morbidity. This study evaluates the efficacy of TXA in reducing blood loss following vaginal delivery. METHODS This was a double-blind randomized placebo-controlled study on the efficacy and safety of intravenous TXA in reducing blood loss in women undergoing vaginal delivery in a tertiary hospital. Data analysis was conducted with IBM SPSS software (version 20, Chicago II, USA). P-value < 0.05 was considered statistically significant. RESULTS The mean estimated blood loss was lower in TXA compared with the placebo group. (174.87 ± 119.83 ml versus 341.07 ± 67.97 ml respectively; P < 0.0001). PPH (blood loss > 500 ml) was 5.13% in the study arm compared to the control arm 7.14%- risk ratio (RR) 0.71; 95% CI: 0.38-1.79, p = 0.5956]. Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007. There were no major complications noticed in the treatment group. CONCLUSION This study demonstrated that intravenous administration of TXA reduced blood loss following vaginal delivery. It also reduced the need for additional uterotonics. However, blood loss greater than 500 was not significantly reduced. TRIAL REGISTRATION This trial was registered retrospectively. Pan African Clinical Trial Registry: PACTR202010828881019 on 12/10/2020.
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10.
Use of tranexamic acid in decreasing blood loss during and after delivery among women in Africa: a systematic review and meta-analysis
Eyeberu A, Getachew T, Amare G, Yadeta E, Lemi M, Bekele H, Negash A, Degefa M, Balcha T, Balis B, et al
Archives of gynecology and obstetrics. 2022
Abstract
BACKGROUND Africa is a developing continent with a high maternal mortality rate. It is beneficial to implement interventions that alleviate the problem. As a result, this systematic review and meta-analysis was carried out to summarize evidence that will assist concerned bodies in proposing strategies to reduce maternal mortality due to post-partum hemorrhage. METHODS This systematic review and meta-analysis includes randomized control trials (RCT) studies searched from various databases (PubMed, Web of Sciences, SCOPUS, African Journal Online, Clinical trials, and African indexes Medics). Data synthesis and statistical analysis were conducted using a combination of review manager 5.3 and STATA Version 14 software. The effect measure utilized was the standardized mean difference for estimated mean blood loss and mean hemoglobin level. RESULTS This systematic review and meta-analysis includes a total of 3308 women. The pooled standardized mean difference showed that tranexamic acid statistical significantly reduced the estimated amount of blood loss after vaginal delivery (standardized mean difference with 95% CI - 0.93 [- 1.45, - 0.41]) and during and after cesarean delivery (standardized mean difference with 95% CI - 1.93 [- 2.40, - 1.47]). CONCLUSION Tranexamic acid has been found to be a good choice for reducing blood loss during and after delivery in Africa regardless of the mode of delivery. Tranexamic acid had no effect on hemoglobin levels before and after delivery. To reduce maternal mortality due to post-partum hemorrhage, it is critical to implement and strengthen interventions aimed at increasing tranexamic acid uptake in Africa.