scholarly journals A comparative study on placebo and trenaxamic acid for the prophylaxis is of post-partum hemorrhage: a randomised double-blind control study

Author(s):  
S. Parveen ◽  
G. Kesava Chandra ◽  
K. Ravindra Reddy ◽  
A. V. Kavya Sree ◽  
M. Varalakshmi ◽  
...  

Background: Obstetric haemorrhage accounts for 20-25% of maternal mortality and morbidity. Anti-fibrinolytics are being widely used in field of surgery. It is also used to reduce heavy menstrual blood loss. The aim of this study was to analyse the effectiveness of TXA in reducing blood loss during normal vaginal delivery.Methods: The randomized double-blind control study was done in the Labour ward. It was conducted on 100 women undergoing Normal vaginal delivery. They were allocated to either Study or Control group by randomization. TXA was given during the Third stage of delivery in study group in addition to the routine care whereas the control group had routine care alone. Blood loss was measured in both groups by bag method.Results: The significant of reduction in blood loss calculated from placental delivery to 2hrs. 141.9 ml in study group versus 270.4 ml in control group. Among primi patients, the control group average blood loss was 325ml, the study group avg blood loss was 169ml. Among G2 patients, the control group average blood loss was 248.5ml. The study group average blood loss was 128.25ml. Among G3 patients, the control group average blood loss was 203ml, the study group average blood loss was 115ml.Conclusions: TXA significantly reduced the amount of blood loss during normal vaginal delivery. Thus, TXA can be used safely and effectively in subjects undergoing normal vaginal delivery.

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
K M Diab ◽  
R M Mohamed ◽  
A G Abdelhay

Abstract Background Postpartum hemorrhage (PPH) is the leading cause of maternal mortality. All women who carry a pregnancy beyond 20 weeks’ gestation are at risk for PPH and its sequelae. Although maternal mortality rates have declined greatly in the developed world, PPH remains a leading cause of maternal mortality elsewhere. Aim of the Work To assess the efficacy and safety intravenous tranexamic acid in reduction of amount of blood loss in high risk women who deliver by cesarean section or vaginal delivery in postpartum period. Patients and Methods This prospective double blind randomized controlled clinical trial study was conducted on 200 patients planned for LSCS or vaginal delivery at Gestational Age ≥ 34 Weeks at Ain Shams University Maternity Hospital. Recruitment of data begun once the protocol was approved by research and ethical committee of the department of obstetrics and gynecology. Results No significant difference between Study and Control groups as regards age (p = 0.508), no significant difference between Study and Control groups as regards Gestational age (p = 0.447),total blood loss (p < 0.001) was significantly lower in study group than control group, Vaginal pads in the 1st 24 hours post-partum was significantly less soaked in study group than control group (p < 0.001). no significant difference between Study and Control groups as regards Preoperative Hemoglobin, Postoperative Hemoglobin was significantly higher in study group than control group (p < 0.001), Reduction in Hemoglobin was significantly less in study group than control group (p < 0.001), no significant difference between Study and Control groups as regards Preoperative Hematocrite, Postoperative Hematocrit was significantly higher in study group than control group (p < 0.001), Reduction in Hematocrite was significantly less in study group than control group (p < 0.001).Need to iron replacement or blood transfusion was significantly less frequent in study group than control group (p = 0.24). Conclusion The use of tranexamic acid prior to cesarean section or vaginal delivery is effective as a prophylaxis against post-partum hemorrhage as shown by the results of this study. It can significantly reduce blood loss during and after cesarean section or vaginal delivery.


Author(s):  
Nagajyothi Gunturu ◽  
D. Shivani ◽  
P. Sravanthi

Background: The aim was to study the efficacy of tranexamic acid in reducing blood loss after childbirth in normal vaginal delivery and LSCS.Methods: 200 pregnant women divided into two groups group 1 and group 2, 100 women undergoing LSCS and 100 women undergoing vaginal delivery. Study group will be given 1 g iv tranexamic acid along with active management of third stage of labor and control subjects will be given only active management of third stage. Clinical observations and laboratory examinations, measurement of blood loss were measured.Results: Distribution with respect to indication of LSCS like fetal distress, cephalopelvic disproportion, abnormal presentation, previous LSCS, arrest of descent, failed induction and onset of labor were comparable between both the groups. Study group showed marked decrease in blood loss when compared to controls from time of placental delivery to 2 hours postpartum in women undergoing vaginal delivery and caesarean section. There was a significant fall in mean Hb level among the control group when compared with the study group. There was no significant difference in the vital signs of the subjects in both the groups. The incidence of adverse effect like nausea, vomiting and diarrhoea were not increased in the study group when compared to the control group. Also the incidence of thrombosis was not increased with tranexamic acid.Conclusions: Tranexamic acid significantly reduced the amount of blood loss after vaginal delivery and lower segment caesarean section. Its use was not associated with any adverse drug reactions like nausea, vomiting, diarrhoea or thrombosis. Tranexamic acid can be safely administered in pregnant women undergoing vaginal delivery and lower segment caesarean section. 


Author(s):  
Anusha Ginjupalli ◽  
Anuradha S. N. ◽  
Joshi Suyajna D.

Background: The use of anti-fibrinolytic therapy has potential to reduce obstetric blood loss due to profound changes that take place in the fibrinolytic system during normal childbirth. Objective was to evaluate the efficacy of tranexamic acid in reducing postpartum hemorrhage (PPH) during normal labour.Methods: Patients who planned for normal delivery and fulfilling the inclusion criteria were recruited for the study. The pre-delivery parameters -pulse rate, blood pressure, Hb gm% and PCV% were measured for each patient. The study group received injection oxytocin (10 IU) and injection tranexamic acid (500 mg) slow intravenous route. The control group received injection oxytocin (10 IU) and placebo injection. Immediately after delivery of the anterior shoulder of the baby, when all the liquor was drained, Brasse-V drape is placed under the patient. Then the patient was given pre-weighed pads, which were weighed 2 hours post-partum. Final blood loss was calculated by combining amount of blood collected in the drape and blood absorbed by the pads.Results: The total number of patients studied was 300- equally distributed in both the groups. There was a significant increase in the pulse rate and decrease in blood pressure in the control group compared to the study group. The post-delivery haemoglobin and haematocrit were significantly reduced in the control group. The blood loss was significantly low in the study group. The need for other uterotonics, blood transfusion, and duration of hospital stay, were significantly low in study group.Conclusions: Tranexamic acid, when given prophylactically to the women with vaginal delivery who received prophylactic oxytocin, appears to reduce the blood loss effectively compared to placebo alone.


2020 ◽  
Author(s):  
Fang Wang ◽  
Nanjia Lu ◽  
Xiaofeng Weng ◽  
Yanping Tian ◽  
Shiwen Sun ◽  
...  

Abstract Background Postpartum hemorrhage (PPH) is a major obstetric complication, and the real-time measurement of blood loss is important in the management and treatment of PPH. We designed a new two-set liquid collection bag (TSLCB) for measuring postpartum blood loss in vaginal delivery. The aim of this study was to evaluate the effectiveness of the TSLCB in separating the blood from the amniotic fluid during vaginal delivery and in determining the accuracy of the measured postpartum blood loss.Methods A prospective, randomized, case control study was conducted in the Women’s Hospital, Zhejiang University School of Medicine, from March 2018 to April 2018. Sixty single pregnant women with spontaneous labor at 37–41 weeks without maternal complications were randomly divided into the experimental and control groups. The TSLCB was used to evaluate separately the amount of blood and amniotic fluid. For the control group, visual estimation and traditional plastic blood-collecting consumables were used to estimate the amount of postpartum blood loss. The measured blood loss between the two groups was compared, and the association of the measured blood loss with various clinical lab indices and vital signs was investigated. Results The TSLCB (the experimental group) improved the detection of the measured blood loss compared with visual estimation and the traditional method (the control group) (p < 0.05). In the experimental group, correlation analysis showed that the measured blood loss at delivery and within 24 h of delivery was significantly associated with the decreased hemoglobin level, red blood cell count, and hematocrit level of patients (r = -0.574, -0.455, -0.437; r = 0.-595, -0.368, -0.374; p < 0.05). In the control group, only the measured blood loss within 24 h of delivery was associated with the decreased hemoglobin level (r = -0.395, p < 0.05). No blood transfusion and plasma expanders were required in the treatment of PPH for both groups.Conclusions The TSLCB can be used to accurately measure the postpartum blood loss in vaginal delivery by medical personnel.Trial registration: This trial was registered with Chinese Clinical Trial Registry (ChiCTR): ChiCTR-IOR-17012453, 23 August 2017.


PEDIATRICS ◽  
1981 ◽  
Vol 68 (6) ◽  
pp. 913-913
Author(s):  
Stephen F. Garrison

In regard to the article, "Indomethacin Treatment for Symptomatic Patent Ductus Arteriorus: A Double-Blind Control Study" (Pediatrics 67:647, 1981), I feel that the study is invalidated because of poor controls. The authors state, "Despite randomization, however, in phase 2 the indomethacin-treated infants were significantly larger and more mature than the corrsponding control subjects, 1.39 ± 0.1 kg and 31.4 ± 0.5 weeks vs 1.1 ± 0.1 kg and 29 ± 0.4 weeks, respectively." A statistical difference of 2 weeks of gestational age could account for the increased morbidity and mortality of the control group.


2021 ◽  
Author(s):  
Francis Igboke ◽  
Lucky Lawani ◽  
Vitus Obi ◽  
Ikechukwu Dimejesi

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


Author(s):  
Supriya Raina ◽  
V. Suguna ◽  
Padmaja Prabraju

Background: The practice of caesarean section is increasing day by day. Delivery by caesarean section can cause more complications than normal vaginal delivery and one of the most common complications is primary or secondary postpartum hemorrhage. The aim of present study was to study the efficacy and safety of tranexamic acid in reducing blood loss during and after caesarean section.Methods: This study was conducted at Deccan College of Medical Sciences, Hyderabad. It was a prospective randomized double blind placebo controlled study. This study includes 60 pregnant women divided in to two groups. Just before the induction of anesthesia 1 gm of tranexamic acid in 20 ml of normal saline was given over 10 minutes in test group and 20 ml of normal saline was infused in control group.Results: The demographic characters of patients in two groups were comparable. There was no statistically significant difference in the heart rates, respiratory rates and blood pressures in the two groups. There was statistically significant difference in the quantity of the blood loss from during the operation and 2 hours postpartum (p=0.003). Total mean blood loss in control group was 718.80±233.1 ml and in study group was 554.28±207.8 ml. The drop in hemoglobin after caesarean section in study group was not significant where as in control group was significant. There was no significant difference in the prothrombin time and partial thromboplastin time in the groups, pre and post operatively. In this study the use of tranexamic acid reduced the dose of other uterotonics like syntocin in study group.Conclusions: Tranexamic acid significantly reduced the amount of blood loss during the caesarean section and also reduced the use of other uterotonics. Thus, tranexamic acid can be used safely and effectively in subjects undergoing caesarean section.


Author(s):  
Nandhini C. C. ◽  
Shanmugapriya .

Background: Obstetric blood loss can be reduced by using anti-fibrinolytic agents.Methods: 200 patients undergoing normal vaginal delivery and fulfilling the inclusion criteria were recruited for the study. In each patient pre-delivery and post-delivery vital parameters and blood indices were noted. The study group received injection tranexamic acid while the control group received only placebo injection in addition to the active management of third stage of labour. The amount of blood loss immediately after delivery and 2 hours after delivery were measured using blood drape and pre-weighed pads respectively.Results: There was a significant increase in the pulse rate and decrease in blood pressure in the control group. The post-delivery hemoglobin and hematocrit were significantly reduced in the control group. The blood loss at the end of 2 hours was more in the control group. The usage of additional uterotonics, need for blood transfusion, and duration of hospital stay was also increased in the control group.Conclusions: Tranexamic acid injection, an antifibrinolytic agent given intravenously after the delivery of the baby appears to reduce blood loss during normal vaginal delivery effectively.


2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Nevein Gerges Fahmy ◽  
Fahmy Saad Latif Eskandar ◽  
Walid Albasuony Mohammed Ahmed Khalil ◽  
Mohammed Ibrahim Ibrahim Sobhy ◽  
Amin Mohammed Al Ansary Amin

Abstract Background Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity worldwide. It is believed that hemostatic imbalance secondary to release of tissue plasminogen activator (tPA) and subsequent hyperfibrinolysis plays a major role in PPH pathogenesis. Antifibrinolytic drugs such as tranexamic acid (TXA) are widely used in hemorrhagic conditions associated with hyperfibrinolysis. TXA reduced maternal death due to PPH and its use as a part of PPH treatment is recommended, and in recent years, a number of trials have investigated the efficacy of prophylactic use of TXA in reducing the incidence and the severity of PPH. The study is aiming to assess the efficacy of tranexamic acid in reducing blood loss throughout and after the lower segment cesarean section and reducing the risk of postpartum hemorrhage. Results The amount of blood loss was significantly lower in the study group than the control group (416.12±89.95 and 688.68±134.77 respectively). Also the 24-h postoperative hemoglobin was significantly higher in the study group (11.66±0.79 mg/dl) compared to the control group (10.53±1.07mg/dl), and the 24-h postoperative hematocrit value was significantly higher in the study group (34.99±2.40) compared to control (31.62±3.22). Conclusion Prophylactic administration of tranexamic acid reduces intraoperative and postoperative bleeding in cesarean section and the incidence of postpartum hemorrhage.


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