The effect of prophylactic intravenous tranexamic acid on blood loss after vaginal delivery in women at low risk of postpartum haemorrhage: a double-blind randomised controlled trial

2015 ◽  
Vol 55 (1) ◽  
pp. 53-58 ◽  
Author(s):  
Mojgan Mirghafourvand ◽  
Sakineh Mohammad-Alizadeh ◽  
Fatemeh Abbasalizadeh ◽  
Mina Shirdel
Keyword(s):  
Randomised Controlled Trial ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Vaginal Delivery ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Low Risk ◽  
Double Blind ◽  
Randomised Controlled

scholarly journals Prophylactic Administration of Per Rectal Misoprostol vs Intramuscular Injection of Oxytocin in Third-stage of Labour for Prevention of Postpartum Haemorrhage: A Randomised Controlled Trial

2021 ◽  
Author(s):  
Sougata Kumar Burman ◽  
Ritwik Samanta ◽  
Kumari Kanak Lata ◽  
Jayeeta Mukherjee ◽  
Tapan Kumar Dey
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Effective Control ◽  
Control Group ◽  
Third Stage ◽  
The Mean ◽  
Randomised Controlled

Introduction: In India, the routine Active Management of Third- Stage of Labour (AMTSL) with conventional intramuscular oxytocin, at the rural, resource-constrained areas, is often compromised due to lack of trained healthcare personnel and proper maintenance of cold chain system, causing maternal mortality and morbidity from Postpartum Haemorrhage (PPH). In these scenarios, tablet misoprostol, can be efficacious and convenient alternative. Aim: To evaluate efficacy and safety of misoprostol administered per rectum with respect to intramuscular oxytocin for effective control of PPH in a Randomised Controlled Trial (RCT). Materials and Methods: In this RCT, conducted in Sambhunath Pandit Hospital, kolkata, West Bengal, India from September 2015 to August 2016, total 80 eligible pregnant mothers in normal labour with prior consent and fulfilled criteria, were allocated to two separated groups (n=40) by computer generated randomisation table. Control group received 10 IU injection oxytocin and case group received 600 μg misoprostol tablet per rectally within one minute of cord clamping and cutting. The primary outcome measures were mean third- stage and mean postpartum blood loss up to eight hours after delivery. Secondary outcome variables were Mean Arterial Pressure (MAP) after eight hours postdelivery, haemoglobin and haematocrit after 24 hours of delivery and reported side effects. Data was entered into a Microsoft excel spreadsheet and statistical analysis was done by Statistical Package for the Social Sciences (SPSS) version 20.0.1 and Graph Pad Prism version 5.0. Results: Total sample size was 80 equally divided into two groups, with a mean age of 23.20±3.1558 years and 23.7750±3.8927 years in case and control group respectively. The mean third-stage blood loss (332.4105±72.6632 mL versus {vs} 329.0088±59.4503 mL, p=0.8193) and mean total blood loss (426.5575±80.0215 mL vs 424.8783±61.5808 mL, p=0.9165) were statistically indifferent between misoprostol and oxytocin groups by two-sample t-tests. The mean for eight hours postpartum MAP (p=0.0894), 24 hours postpartum haemoglobin (p=0.4534) and haematocrit (p=0.1325) were statistically insignificant between the two groups by two- sample t-tests. Incidence of adverse effects like shivering, diarrhoea, compared by Pearson’s Chi-square test, were found to be more but non significant in misoprostol group. Conclusion: This study concludes that per-rectal misoprostol is equally effective as intramuscular oxytocin to control PPH without significant adverse effects.

scholarly journals Intramuscular versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery: randomised controlled trial

BMJ ◽  
2018 ◽  
pp. k3546 ◽  
Author(s):  
Nita Adnan ◽  
Rebecca Conlan-Trant ◽  
Ciara McCormick ◽  
Fiona Boland ◽  
Deirdre J Murphy
Keyword(s):  
Randomised Controlled Trial ◽  
Vaginal Delivery ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial.

2021 ◽  
Author(s):  
Francis Igboke ◽  
Lucky Lawani ◽  
Vitus Obi ◽  
Ikechukwu Dimejesi
Keyword(s):  
Treatment Group ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Vaginal Delivery ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Estimated Blood Loss

Abstract Background: Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide with the highest incidence in the developing countries. Tranexamic acid (TXA) is a useful drug for prevention of PPH and merits evaluation in our environment. 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±119.84 ml versus 341.07±67.97 ml respectively; P<0.0001). PPH (blood loss >500ml) was 5.13% in the study arm compared to the control arm 7.14%- risk ratio (RR) 0.82; 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%) of the treatment group, p-value of 0.007. There were no major complications noticed in the treatment group.Conclusion: This study demonstrated that intravenous administration of TXA acid following vaginal delivery reduced blood loss following vaginal delivery. It also reduced the need for additional uterotonics. However, blood loss greater than 500 was not significantly reduced.Pan African Clinical Trial Registry: PACTR202010828881019

scholarly journals Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032642
Author(s):  
Yu Zhang ◽  
Yuan Jia ◽  
Jia Shi ◽  
Su Yuan ◽  
Rong Wang ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Randomised Controlled Trial ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Small Sample ◽  
Double Blind ◽  
End Point ◽  
Paediatric Patients ◽  
Paediatric Cardiac Surgery ◽  
Randomised Controlled

IntroductionAn initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery.Methods and analysisThis will be a single-centre prospective, double-blind randomised controlled trial. The plan is to enrol in the study 2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB). All eligible participants will be randomly assigned to either the TXA or placebo group by using a Web-based randomisation service in a 1:1 ratio. The primary safety end point will be postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB. All patients will be followed up for 1 year postdischarge. All data will be analysed in accordance with the intention-to-treat principle.Ethics and disseminationThis study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.Trial registration numberChinese Clinical Trial Register (ChiCTR1900024131).

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