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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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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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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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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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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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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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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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Effects of tranexamic acid on the amount of bleeding following vaginal delivery and its adverse effects: a double-blind placebo controlled randomized clinical trial
Kashanian M, Dadkhah F, Tabatabaei N, Sheikhansari N
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2021;:1-5
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Full text
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Editor's Choice
Abstract
INTRODUCTION Postpartum hemorrhage (PPH) is the most important concern after delivery. Tranexamic acid (TXA), an anti-fibrinolytic agent, has been suggested for prevention and treatment of PPH. OBJECTIVE The purpose of the present study was to find the effects of TXA on the amount of bleeding following vaginal delivery and its adverse effects. MATERIALS AND METHODS The study was performed as a randomized double blind placebo controlled clinical trial on low risk pregnant women who delivered vaginally. The patients were randomly assigned into two groups. Women in the intervention group received 10 mg/kg infusion of TXA in 100 mL normal saline and the control group received one vial of distilled water (as placebo) in 100 mL normal saline. The primary outcome was amount of bleeding after delivery. The secondary outcomes were decreased in hemoglobin level, need for additional uterotonic agents and need for blood transfusion. All were evaluated 6 h after delivery and compared in the two groups. Participants were followed up to six weeks after delivery for any TXA side effects. RESULTS Two hundred and seven women finished the study. There were no significant differences between the two groups in terms of demographic data and risk factors for bleeding. Mean blood loss and need to misoprostol was more in the control group (p=.033 and p=.000, respectively). Hemoglobin level was higher in the TXA group 6 h after delivery. None of the subjects needed blood transfusion, uterine balloon tamponade or emergency hysterectomy. Adverse effects were higher in the TXA group, however, there were no side effects between weeks 3 and 6 in both groups. There were no thromboembolic events during six weeks after delivery. CONCLUSIONS Tranexamic acid can reduce the amount of bleeding after vaginal delivery in low risk women without having serious complications. Also, it may decrease the need for additional uterotonic agents. Trial registration number and registry website: IRCT20091023002624N22.
PICO Summary
Population
Low risk pregnant women who delivered vaginally (n= 207).
Intervention
Tranexamic acid (TXA), (n= 104).
Comparison
Placebo (n= 103).
Outcome
There were no significant differences between the two groups in terms of demographic data and risk factors for bleeding. Mean blood loss and need for misoprostol was higher in the control group. Haemoglobin level was higher in the TXA group 6 hours after delivery. None of the women needed blood transfusion, uterine balloon tamponade or emergency hysterectomy. Adverse effects were higher in the TXA group, however, there were no side effects between weeks 3 and 6 in both groups. There were no thromboembolic events during six weeks after delivery.
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Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding
Rahman S, Khan FS, Samin KA, Afridi N, Ahmed M
Cureus. 2021;13(10):e19122
Abstract
Introduction Heavy menstrual bleeding (HMB) is characterized by high blood loss (>80 mL per cycle) at regular menstrual intervals. It can have an impact on a woman's bodily, mental, and/or material well-being. The etiology is varied and can be local, systemic, or iatrogenic. The occurrence of HMB is between 4% and 27%, depending on objective menstrual bleeding measurements and on high estimates based on subjective bleeding measures. This study was conducted to assess the efficacy of oral tranexamic acid versus combined oral contraceptive (COC) pills in the management of excessive menstrual bleeding. Methodology A comparative study was conducted at the Obstetrics and Gynecology Department of Combined Military Hospital Peshawar, Pakistan, from October 2020 to March 2021. Women aged above 18 years who presented with heavy menstrual bleeding (HMB) were included in the study. The exclusion criteria included all women with contraindications to the use of tranexamic acid, such as lactating mothers, pregnancy, use of oral contraceptives or steroids, history of renal malfunction or stroke, family history of thromboembolic disease, and ovarian or endometrial carcinoma. Patients with diagnosed leiomyomas with a size between >1 and 10 cm were included in the study. Women were allocated randomly into group A who received oral tranexamic acid 3.9-4 g per day or group B who received oral COC pills containing a combination of ethinyl estradiol 30 μg and norgestrel 0.3 mg. The efficacy of treatment was considered successful if there was a mean reduction in menstrual blood loss that was significantly greater than the baseline values. Results There were 178 patients in total, with 89 patients in each group. It was found that both oral tranexamic acid and combined oral contraceptives were equally effective in reducing the mean blood loss among patients and there was no statistical difference observed between the two groups. Upon stratification, it was found that both treatment groups were highly effective in younger age groups. Similarly, there was no significant difference in efficacy with respect to diabetes mellitus or hypertension. However, in individuals with leiomyomas, efficacy was significantly higher in patients who were in group B (combined oral contraceptives) (p = 0.004), and 46.1% of women in group A and 60.6% of women in group B did not experience any discomfort. Conclusion The current study revealed that both oral tranexamic acid and COC pills were equally effective in reducing the mean blood loss among patients with HMB. It was further found that the efficacy of both therapies was significantly higher in younger age groups. The efficacy of therapy was significantly reduced with the increasing age of the patient. Moreover, it was found that patients with leiomyomas benefitted more significantly from COC pills. There were no severe adverse effects reported in the study. However, future researches can explore the long-term side effects of both therapies. In short, both therapies were comparable in terms of efficacy and safety. Heavy menstrual bleeding can negatively impact a woman, emotionally and physically. Therefore, it is encouraged that physicians use their expert judgment while prescribing either oral tranexamic acid or COC pills to patients with HMB.
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Prophylactic use of tranexamic acid for decreasing the blood loss in elective cesarean section: A placebo-controlled randomized clinical trial
Naeiji Z, Delshadiyan N, Saleh S, Moridi A, Rahmati N, Fathi M
Journal of gynecology obstetrics and human reproduction. 2020;:101973
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Editor's Choice
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.
PICO Summary
Population
Pregnant women scheduled for elective caesarean section (n= 200).
Intervention
Intravenous tranexamic acid diluted in dextrose (n=100).
Comparison
Placebo: intravenous distilled water diluted in dextrose (n= 100).
Outcome
Tranexamic acid decreased the mean blood loss by 25.3 %. Mean volume of intra-operative blood loss was 391.1 (±67.4) ml in tranexamic acid group and 523.8 (±153.4) ml in placebo 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.