Management Of Postpartum Hemorrhage Research Articles

A comparative study between misoprostol combined with oxytocin versus oxytocin alone in reducing post-partum blood loss

Background: Oxytocin remains as the first line utero-tonic drug used in the management of postpartum hemorrhage (PPH). Because of its certain disadvantages, another cost effective uterotonic drug which can be used orally or vaginally with good absorption is misoprostol, which is a prostaglandin E1 analogue. The study aimed to compare and evaluate the effectiveness of oxytocin versus oxytocin plus misoprostol in the prevention of PPH. Materials and methods: A prospective randomized interventional study was conducted on 160 term pregnant women from February 2019 to August 2019. The study subjects were randomized into two groups of 80 each. During the active management of third stage of labour, all patients in the study group were administered with standard drug treatment of 10 IU of oxytocin through intramuscular route along with 600µg of misoprostol given sublingually, whereas the patients in the control group were given only 10IU of oxytocin alone. Results: The average postpartum blood loss and the need for blood transfusion were significantly higher among the control group compared to the study group. The overall incidence of PPH was found to be 28.5% among the control group and it was 6.4% among the study group. Adverse events such as fever, shivering, nausea, vomiting and diarrhoea were more among the study group than that of the control. Conclusion: A single dose of 600µg of sublingual misoprostol as an adjunct to standard 10 units of intramuscular oxytocin was found to be more effective in reducing blood loss than using 10 units of intramuscular oxytocin alone in the Active Management of Third Stage of Labour.

Role of recombinant factor VIIa in the clinical management of severe postpartum hemorrhage: consensus among European experts

Objectives There have been significant advances in the medical management of severe postpartum hemorrhage (sPPH) over recent decades, which is reflected in numerous published guidelines. To date, many of the currently available national and international guidelines recommend recombinant factor VIIa (rFVIIa) to be used only at a very late stage in the course of sPPH, as a “last resort”, before or after hysterectomy. Based on new safety data, rFVIIa has recently been approved by the European Medicines Agency (EMA) and Swissmedic for use in sPPH, if uterotonics are insufficient to achieve hemostasis, which in fact is significantly earlier in the course of postpartum hemorrhage (PPH). We therefore aimed to develop expert consensus guidance as a step toward standardizing care with the use of rFVIIa for clinicians managing women experiencing life-threatening sPPH. Methods The consensus process consisted of one face-to-face meeting with a group of nine experts, including eight obstetrician-gynecologists and a hematologist highly experienced in sPPH care in tertiary care perinatal centers. The panel was representative of multidisciplinary expertise in the European obstetrics community and provided consensus opinion in answer to pre-defined questions around clinical practice with rFVIIa in the management of sPPH. Recommendations have been based on current national and international guidelines, extensive clinical experience, and consensus opinion, as well as the availability of efficacy and new safety data. Results The expert panel developed 17 consensus statements in response to the 13 pre-defined questions on the use of rFVIIa in the management of sPPH including: available efficacy and safety data and the need for interdisciplinary expertise between obstetricians, anesthesiologists, and hematologists in the management of sPPH. Based on novel data, the experts recommend: (1) earlier administration of rFVIIa in patients with sPPH who do not respond to uterotonic administration to optimize the efficacy of rFVIIa; (2) the importance of hematological parameter prerequisites prior to the administration of rFVIIa to maximize efficacy; and (3) continued evaluation or initiation of further invasive procedures according to standard practice. Furthermore, recommendations on the timing of rFVIIa treatment within the sPPH management algorithm are outlined in a range of specified clinical scenarios and settings, including vaginal delivery, cesarean section, and smaller birthing units before transfer to a tertiary care center. The panel agreed that according to available, and new data, as well as real-world experience, there is no evidence that the use of rFVIIa in patients with sPPH increases the risk of thromboembolism. The authors acknowledge that there is still limited clinical effectiveness data, as well as pharmacoeconomic data, on the use of rFVIIa in sPPH, and recommend further clinical trials and efficacy investigation. Conclusions This expert panel provides consensus guidance based on recently available data, clinical experience, and expert opinion, augmented by the recent approval of rFVIIa for use in sPPH by the EMA. These consensus statements are intended to support clinical care for sPPH and may help to provide the impetus and a starting point for updates to existing clinical practice guidelines.

"How I wish we could manage such things": A qualitative assessment of barriers to postpartum hemorrhage management and referral in Kenya.

Maternal mortality rates in Kenya have remained high, with the country reporting 342 deaths per 100,000 live births. A major contributor to this is postpartum hemorrhage (PPH), responsible for 40% of maternal deaths in Kenya and the leading cause globally, particularly in low- and middle-income countries. Timely and effective PPH care is crucial; however, challenges arise when referrals between facilities become necessary. Although Primary health care facilities (PHCs) in Kenya oversee many births and are crucial in PPH risk detection and management, they often fall short due to ill-equipped facilities and inefficient referral systems. This study traced PPH patients from tertiary institutions to their initial PHCs. Through qualitative interviews with healthcare providers, we aimed to examine the primary challenges in PPH management and referral decision-making. We found that, in addition to structural gaps, challenges in collaboration and communication between providers from different health facilities, which may also stem from inadequate training, greatly influenced referral efficacy. Our findings are pivotal for maternal health discourse and policy. Importantly, while many solutions focus on structural inputs, our study underscores the importance of communication between facilities in ensuring timely care. Our findings suggest a need for bolstered emergency preparedness, informed clinical decision-making, and strategic interventions where they are most impactful.

Identifying the needs of women following a severe postpartum hemorrhage.

Childbirth is a unique experience for women. In Ireland, major obstetric hemorrhage (MOH) is the most frequently reported severe maternal morbidity (SMM) with an incidence of 3.27 per 1000 maternities. Much is known now about the management of postpartum hemorrhage (PPH), and there is some research on women and their partner's experience. Less is known about how the woman feels emotionally following a PPH or what informational needs and emotional support are required. The aim of this study was to understand how women felt after experiencing a severe PPH, to listen to their first-hand experience, and to learn what improvements could be made for future care for women who experience a PPH. A descriptive, quantitative approach was conducted using semi-structured interviews with women who had a severe hemorrhage (blood loss) of ≥2.5 L between four and fourteen months postpartum. Five women took part in this study. The women identified a lack of information provided to them about the reason for the significant bleeding. The women voiced they could overhear information about the event discussed between healthcare professionals but not with the woman. The care the women received in the High Dependency Unit (HDU) was significantly different from the care they received in the postnatal wards, and the women were not informed they were clinically well for transfer to the postnatal ward. It was reported that the postnatal wards were busy and short-staffed, and the women looked for more emotional support from staff, which was not available. This had an effect on their recovery in the postnatal period. The women reported that they wanted more information in the early postnatal period following the event, and some still had unanswered questions at the time of the interviews several months later. Most of the participants did not receive adequate emotional support from the midwives caring for them, which resulted in the participants requesting early discharge home to get emotional support from members of their family.

74 Predictors of intrauterine vacuum-induced device failure in management of postpartum hemorrhage: a multicenter experience

74 Predictors of intrauterine vacuum-induced device failure in management of postpartum hemorrhage: a multicenter experience

Examining lecturers’ questions and level of reflection during post-simulation debriefing in Malawi: A qualitative study

BackgroundSimulation-based education has recently been promoted among midwifery students in Malawi. Reflective debriefing is essential for a successful educative simulation. It is therefore crucial to explore debriefing practice, particularly when simulation-based education is novel. Therefore, the study aimed to explore practice of debriefing with focus on level of reflection in questions posed by lecturers and responses from midwifery students when learning postpartum haemorrhage MethodsThe study applied qualitative exploratory design. During debriefing of a simulation session on postpartum hemorrhage management, data were collected through audio recordings. Seven midwifery lecturers and 107 midwifery students from midwifery education program in Malawi participated in the study. Using Gibbs’s reflective cycle, data from the lecturers’ questions and midwifery students’ responses were analysed by rating stages of reflection. The reporting of the results follows Consolidated Criteria for Reporting Qualitative Research. ResultsMost of lecturers’ questions and midwifery students’ responses were evaluative, 46% and 47%, respectively. The fewest questions and responses were conclusive, 4% and 2% respectively. Only 12% of the lecturers’ questions were analytic, while 16% of students’ responses were rated as analytic. ConclusionThe results revealed that debriefing provides a forum for students to reflect on their simulated experience. Though, more evaluative questions and responses were elicited from lecturers and students, respectively, than the rest of the stages in Gibbs’s reflective cycle. If debriefing in simulation-based education is going to pave the way for student reflection in Malawi, it is necessary to enhance debriefing practices through further training.

336 Differences in pharmacologic management of postpartum hemorrhage in patients with and without thrombocytopenia

336 Differences in pharmacologic management of postpartum hemorrhage in patients with and without thrombocytopenia

Two Postpartum Blood Collection Devices: The Brass-V Drape and MaternaWell Tray-As Experienced by Birth Attendants and Birthing Women-A Questionnaire-Based Randomised Study.

Postpartum haemorrhage is the leading cause of preventable maternal mortality worldwide. Early identification and prompt management of postpartum haemorrhage improve outcomes. Objective assessment of postpartum blood loss is an important step in identifying postpartum haemorrhage. The Brass-V drape and MaternaWell tray have been designed for routine measurement of postpartum blood loss. The perceived utility and acceptability of these devices to the parturients and birth attendants still begged exploring. To assess the perceived usefulness and ease of use of a Brass-V drape versus a MaternaWell tray for the collection of postpartum blood loss. We conducted a prospective parallel randomised trial, employing a questionnaire to assess the experiences of birth attendants and birthing women who used these devices. The study was conducted at site B midwife obstetric unit in Khayelitsha Cape Town. Pregnant women presenting in early labour were approached for voluntary participation. After informed consent was obtained, participants were randomly assigned to the Brass-V drape or the MaternaWell tray, which the birth attendant placed after the birth of the baby. There were 63 participants, of which 33 were assigned to the MaternaWell tray and 30 to the Brass-V drape. Birth attendants indicated a desire to use the MaternaWell tray (30 (90%)) or Brass-V drape (26 (87%)) in future deliveries. The parturients were also in favour of the future use of MaternaWell tray (33 (100%)) and Brass-V drape (28 (93%)). Ease of measurement favoured the Brass V-drape, and ease of placement favoured the MaternaWell tray. Five (8%) participants experienced postpartum haemorrhage, two with the MaternaWell tray and three with the Brass-V drape. One parturient required hospital transfer. The responses of the birth attendants and parturients were positive. The MaternaWell tray has the benefit of reuse and lower cost and is an acceptable alternative to the Brass-V drape. Both devices aid in the early recognition of postpartum haemorrhage.

103 Assessing tranexamic acid utilization for management of postpartum hemorrhage at referral facilities in Ghana

103 Assessing tranexamic acid utilization for management of postpartum hemorrhage at referral facilities in Ghana

Tranexamic acid for the prevention and treatment of postpartum hemorrhage in resource-limited settings: a literature review.

Postpartum haemorrhage is a major cause of maternal morbidity and mortality worldwide. Early recognition and appropriate treatment are crucial for managing postpartum haemorrhage. This literature review aimed to evaluate the efficacy of tranexamic acid in the prevention and treatment of postpartum haemorrhage in resource-limited settings. This literature review was conducted based on the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines. A computerized systematic search of the MEDLINE (PubMed), Google Scholar, and Cochrane databases using a combination of the following Medical Subject Headings (MeSH) terms for PubMed: [(obstetric haemorrhage OR postpartum haemorrhage OR massive obstetric haemorrhage) AND (tranexamic acid OR antifibrinolytic drugs) AND (prophylaxis OR prevention) AND (management OR treatment) AND (resource-limited settings OR resource-limited area OR developing countries)] to find articles published in English since 2010. Studies on the obstetric population who underwent vaginal or caesarean delivery, comparing the use of tranexamic acid versus placebo (or no treatment) for treatment (or prevention) of postpartum haemorrhage with the outcome of postpartum haemorrhage rate, blood transfusion requirements, uterotonics requirements, hysterectomy, or mortality were included. In total, 5315 articles were identified. Following the elimination of duplicates, the methodological quality of 15 studies was evaluated independently, with eligibility determined based on the inclusion and exclusion criteria, as well as outcome variables. Finally, eight articles were included in the review. This review provides evidence that the administration of tranexamic acid has the potential to decrease the need for blood transfusion, incidence of postpartum haemorrhage, demand for supplementary uterotonics, and maternal morbidity and mortality with marginal adverse effects. Healthcare systems must develop and implement interventions that involve the use of tranexamic acid for the treatment of postpartum haemorrhage in resource-limited settings.

Comparison of Complication and Post-Operative Infection Rate Between Application of Carbetocin and Oxytocin during Management of Post-Partum Hemorrhage after Caesarean Section

Background: Adverse effects can be produced by carbetocin and oxytocin during management of post-partum hemorrhage after caesarean section. Objective: The purpose of the present study was to compare the adverse effects among women with post-partum hemorrhage after caesarean section. Methodology: This randomized controlled trial was conducted in the Department of Obstetrics and Gynaecology at Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2015 to December 2015 for a period of six months. Pregnant women diagnosed on the standard criteria admitted in BSMMU, Dhaka, Bangladesh were selected as study population by consecutive type of sampling. Randomization was performed according to computer generated simple random sampling method. An Uterotonic was an agent used to induce contraction or greater tonicity of the uterus. Then the patients were monitored per operatively and post operatively. All the information was recorded in data collection sheet. Main outcome variables were estimated blood loss. Results: A total number of 96 pregnant women were recruited for this study of which 48 cases were enrolled in group I and the rest of 48 case were enrolled in group II. The mean age with SD of the group I and group II were 24.4±4.7 years and 24.7±3.7 years. In blood transfusion of the study patients, 2(4.2%) patients need blood transfusion in group I and 5(10.4%) in group II (p>0.05). One (2.1%) patients had anaemia in group I and 5(10.4%) in group II. Forty-six (95.8%) patients had average menstrual flow in group I and 40(83.3%) in group II (p>0.05). Considering the side effect, 1(2.1%) patients had nausea in group I and 4(8.3%) in group II. Two (4.2%) patients had vomiting in group I and 5(10.4%) in group II. One (2.1%) patients had headache in group I and 4(8.3%) in group II. Four (8.3%) patients had infection rate in group I and 5(10.4%) in group II (p>0.05). Conclusion: In conclusion blood transfusion, anaemia, vomiting and infection rate are found less in group I than group II. Bangladesh Journal of Infectious Diseases, December 2023;10(2):59-64

BALLOON TAMPONADE FOR REFRACTORY MANAGEMENT OF POSTPARTUM HAEMMORRHAGE AT LADY READING HOSPITAL PESHAWAR

This study aimed to determine the effectiveness of balloon tamponade in managing postpartum hemorrhage in women who were delivered at Lady Reading Hospital in Peshawar. A descriptive study was conducted from September 2022 to September 2023 in the gynecology ward of Lady Reading Hospital. The study included females aged 18 to 40 years who experienced PPH after delivery and were either primigravida or multigravida. The effectiveness of balloon tamponade was evaluated. The mean age of the participants was 28.75±6.30 years, and the mean gestation age was 37.40±3.06 weeks. The most common cause of PPH was an atonic uterus. The study found that balloon tamponade was effective in 89.8% of cases. The study concludes that balloon tamponade is effective in managing postpartum hemorrhage in 89.8% of cases.

Management of Decreased Consciousness Caused by Hypovolemic Shock ec Postpartum Hemorrhage in Critical Care Setting

Introduction: Postpartum hemorrhage life-threatening condition, with a prevalence of approximately 1%-10% of all deliveries. Postpartum hemorrhage is one of the leading causes of maternal death.
 Case presentation: A 33-year-old female patient came to the emergency department with decreased consciousness 1 hour before hospital admission, with postpartum hemorrhage, placental abruption following cesarean section, and uterine atonia following B-Linch. The patient underwent a B-Linch operation after undergoing a cesarean section at a previous Hospital due to antepartum hemorrhage and placental abruption. The patient also experienced ongoing bleeding during the treatment due to uterine atonia. Following surgery, a post-operative laboratory evaluation revealed significant thrombocytopenia (platelets: 45.000/mm3) and anemia (Hb: 4,6 g/dl). 
 Conclusion: The management of postpartum hemorrhage, especially with shock, requires comprehensive critical care management. Appropriate management with good multidisciplinary team involvement will improve patient outcomes and prevent multi-organ failure.

A Study to Assess the Usage, Perception and Effect of Safe Delivery Application Regarding Emergency Obstetrics and Newborn Care in Final Year Students of Selected Nursing Colleges, NCR

Introduction: Health professionals who oversee routine and complex deliveries in remote places might utilize the Safe Delivery Application, a mobile health tool. The programme includes practical training DVDs on important obstetric procedures that can aid health professionals in putting their newly acquired knowledge into practice and can decrease the rate of infant mortality rate and maternal mortality rate. Objectives: The main objective of the study to assess the usage, perception and effect of safe delivery application regarding emergency obstetrics and newborn care in final year students of selected nursing colleges. Methodology: -The research design for this study was Quasi experimental design to assess the usage, perception and effect regarding SDA. Total enumerative sampling technique were used to select 300 final year nursing students, NCR. Informed written consent was taken from each nursing student. A structured questioners and likert scale were administered to assess the usage, perception and effect for SDA. The collected data was analyzed by using descriptive statistics and inferential statistics. Frequency and percentage distribution was used for demographic variables and assessing the usage, perception and effect among nursing students. Chi-square was used to find out the association between usage and perception among final year nursing students and selected demographic variables. Result: The data obtained was analyzed by using descriptive and inferential statistics. The results show that there was a usage & knowledge gap among nursing students (mean 11.66, SD 3.34) but after using the safe delivery application the post-test scores improved to (mean 20.67 SD 12.26) in terms of usage & perception were significantly higher than the pre-test score. This shows that the safe delivery application was effective in improving the knowledge regarding the usage, perception and effect of SDA regarding final-year nursing students on active management of third-stage labor, postpartum hemorrhage, and neonatal resuscitation were successful.

Instructional and didactic support tool for teaching-learning Post-Partum Haemorrhage care in simulated settings: Creation and validation

ObjectiveTo describe the creation and validation process of an instructional, didactic and self-applied support tool for teaching-learning Post-Partum Haemorrhage care in simulated settings. BackgroundStudents frequently face difficulties performing the actions in the proper sequence in Post-Partum Haemorrhage simulated cases. Even in a controlled environment, anxiety, nervousness and fear of making mistakes are evident, which render the simulated experience highly stressful. Having a tool with a guideline can help students perform these actions more assertively. DesignA methodological study to develop a didactic tool. MethodsThe creation process of the didactic tool, called Instructional Disk for the Management of Post-Partum Haemorrhage, was divided into five phases: Analysis, Design, Development, Implementation and Evaluation. Nine experts specialised in Obstetrics and Midwifery validated the tool by answering a questionnaire with nine items; in turn, 32 undergraduate Midwifery program students carried out the evaluation using a questionnaire on applicability, functionality, clarity, coherence and usability of the tool in Post-Partum Haemorrhage simulated stations. The data were analysed descriptively, considering absolute agreement when the answers to all questions in the five-point Likert scale corresponded to 5 (I totally agree). The Content Validity Index was calculated for the experts' questionnaires. ResultsIn the validation stage, the experts agreed or totally agreed with all nine items, reaching a Content Validity Index = 1. In the total scores assigned by the experts, there was a variation between 80.0% and 100% absolute agreement, with a mean of 95.6%. In the students' assessment, the variation was between 87.5% and 100% absolute agreement, with a mean of 97.7%, in the eight items evaluated. The agreement level above 90% among experts and students was considered high. ConclusionsThe Instructional Disk for the Management of Post-Partum Haemorrhage was validated by experts with extensive experience in Obstetrics and Midwifery care and teaching, ensuring that the content included in the guidelines for the management of Post-Partum Haemorrhage adopted in Brazil is covered. The students positively evaluated this support tool for learning the care to be provided in Post-Partum Haemorrhage cases in the simulated stations.

A Retrospective before and after Assessment of Multidisciplinary Management for Postpartum Hemorrhage

Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity and mortality. While PPH treatment guidelines exist, data on their effect on reduction in red blood cell (RBC) transfusions and use of hemostatic products are scarce. Continuous evaluation of PPH management is important to assess potential pitfalls and incorporate new treatment options. We retrospectively compared PPH management and administration of RBC and hemostatic products before and after international guideline implementation. The primary endpoint was RBC administration for PPH. Secondary endpoints were hemoglobin trigger for RBC administration, administration of hemostatic products and surgical therapies. In total 235 patients had a PPH, 59 in 2011 and 176 in 2018. In 2018, fewer patients received RBC within 24 h (2018: 10% vs. 2011: 32%, p < 0.001) and 24 h after delivery (2018: 4.5% vs. 2011: 37%, p < 0.001). The number of RBC units transfused per case was significantly lower in 2018 (two vs. four units in 2011, p = 0.013). A significantly reduced transfusion of fresh frozen plasma and platelets was observed in 2018 (p < 0.001 and p = 0.002, respectively). In 2011, additional surgeries for PPH in both the acute and subacute phase were performed more frequently. Local implementation of multidisciplinary PPH guidelines is feasible and was associated with a significant reduction in transfused blood products.

Post-partum hemorrhage: a multidisciplinary approach to 'the golden hour' quantum leadership and communication.

Background: Quantum leadership in postpartum hemorrhage (PPH) simulation training remains underexplored. Quantum leaders excel in PPH's chaotic settings, differing from traditional leaders. Aiming: To assess the impact of simulation training on quantum leadership skills in maternity teams. Research design: A quasi-experimental approach. Sample: 60 maternity professionals from Rafik Hariri University Hospital, Lebanon. Tools: Structured interviews, observational checklists and a leadership skills scale. Results: Most participants had limited PPH simulation experience and showedan initial low proficiency. Significant improvements were evident, posttraining. Conclusion: Simulation training enhances quantum leadership in PPH management among maternity professionals.

The incidence, indications, risk factors and pregnancy outcomes of peripartum hysterectomy at a tertiary hospital between 2013 and 2022.

To analyze the incidence, indications, risk factors and pregnancy outcomes of postpartum hemorrhage resulting in peripartum hysterectomy (PH). We retrospectively reviewed patients with postpartum hemorrhage requiring surgical procedures at ≥ 28weeks of gestation from January 1, 2013 to December 31, 2022 at a tertiary hospital in Shanghai, China. The patients were divided into a PH group and a non-PH group. Maternal clinical characteristics, the management of postpartum hemorrhage, pregnancy outcomes were compared between groups. Logistic regression was used to analyze the correlations between risk factors and PH. The incidence of hysterectomy was 0.2/1000 deliveries (31/150194). The variables significantly associated with PH were placenta previa with placenta increta/percreta (OR36.26), uterine rupture (OR266.16) and an estimated blood loss ≥ 3513mL (OR431.11). The proportion of cases involving hemorrhagic shock, disseminated intravascular coagulation, bladder injury, neonatal severe asphyxia, neonatal death and hypoxic-ischemic encephalopathy were significantly higher in the PH group (P < 0.05). The most common indications of PH were placental pathology. Efforts should be made to reduce the rate of cesarean deliveries and uterine curettage to lower the probability of abnormal placental invasion and appropriate medical indications for trial of labor after cesarean should be strictly followed to avoid the risk of uterine rupture.

Effect of a high-fidelity simulation-based teaching-learning experience (SBTLE) on maternal health nursing students' knowledge of postpartum hemorrhage, confidence, and satisfaction

BackgroundPostpartum hemorrhage is the leading cause of maternal mortality worldwide. Preparing nurses to manage postpartum hemorrhage through simulation training has emerged as a successful educational strategy to overcome the challenges related to medical management failures. Simulation holds promising potential to improve patient care, especially for high-risk scenarios, where immediate and rapid interventions are required. ObjectiveThe study assessed the knowledge, confidence, and satisfaction of nursing students before and after participating in a high-fidelity simulation of a patient with postpartum hemorrhage. MethodA pretest–post-test design was used to assess students’ knowledge and a cross-sectional survey was used to assess students’ level of confidence and satisfaction. Data were collected from 88 undergraduate nursing students enrolled in maternity nursing clinical courses in a major public university in Oman during the Spring and Fall semesters, of 2022. ResultThe study findings showed that the simulation significantly increased the students’ knowledge (p value 0.038) and produced respectable levels of satisfaction and confidence 4.05 ± 0.65 among the students. ConclusionOur study findings showed that simulation could be a successful teaching approach to improve student knowledge, satisfaction, and confidence. The results call for educators to integrate the simulation into the nursing curriculum and continue developing scenarios for advanced use in future cohorts.

An integrative analytical approach designed for feasible tranexamic acid assay using o-phthalaldehyde as a fluorogenic probe: applications to tablets, ampoules, and urine.

Antifibrinolytic tranexamic acid (TRX) suppresses plasminogen activation to plasmin in a competitive way. TRX is approved for the management of heavy menstrual periods, hereditary angioedema, hemophilia, postpartum hemorrhage, surgery, tooth extraction, and severe blood loss after acute trauma. Here, the practical use of an isoindole derivative was established for a novel, easy-to-use, and affordable TRX assay. In the presence of a molecule containing a sulfhydryl group (2-mercaptoethanol) 0.02% v/v, the primary amine moiety in TRX allows its combination with o-phthalaldehyde to produce a luminous product. Excitation (338.8nm) and emission (433.9nm) wavelengths were used to monitor the isoindole fluorophore yield, and each operational variable was carefully examined and adjusted. The calibration graph was constructed with fluorescence intensity versus TRX concentration, excellent linearity was observed at concentrations between 40 and 950 ng/ml, and limit of detection and limit of quantitation were 41.3 and 13.6ng/ml, respectively. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines were used to validate the method. The developed method for TRX assay in various dosage forms and urine was successfully implemented and was shown to be an effective, simple, and quick replacement for the TRX assay in clinical trials and quality control.