Prevention Of Postpartum Hemorrhage Research Articles

Carbetocin Use during Caesarean Deliveries in Preventing Postpartum Haemorrhage (PPH) In Enugu: A 15-Case Series and Review of Literature

Carbetocin Use during Caesarean Deliveries in Preventing Postpartum Haemorrhage (PPH) In Enugu: A 15-Case Series and Review of Literature

Practices and factors associated with active management of the third stage of labor in East Africa: systematic review and meta-analysis

BackgroundActive management of the third stage of labor involves prophylactic uterotonics, early cord clamping, and controlled cord traction to deliver the placenta. It is designed to facilitate the delivery of the placenta by increasing uterine contractions during the third stage of labor. It is also used to prevent postpartum hemorrhage by averting uterine atony.This systematic review and meta-analysis’s emphasis was on the practice and factors associated with active management of the third stage of labor in East Africa.MethodsPubMed, Web of Science, Science Direct (Scopus), Google Scholar, African Journals Online, and the Cochrane Library electronic databases were used. Data were extracted using Microsoft Excel, and STATA version 14 was used for analysis. A p-value of 0.05 is regarded to indicate potential publication bias: the funnel plot, Begg, and Egger’s regression test were used to examine publication bias. Using I2 statistics, the heterogeneity of the studies was evaluated. Pooled analysis was carried out. By country, a subgroup analysis was conducted.ResultsThirteen studies were included in this systematic review and meta-analysis. The pooled prevalence of the practice of active management of the third stage of labor in East Africa was 34.42%. Received training (OR = 6.25, 95%CI = 3.69, 10.58), years of experience (OR = 3.66, 95%CI = 2.35, 5.71), and good knowledge (OR = 3.66, 95%CI = 2.35, 5.71) were statically associated with the practice of active management of third stage of labor.ConclusionThe pooled prevalence of practice for active management of the third stage of labor in East Africa was low. Factors that were statistically associated with the practice were received training, years of experience, and good knowledge. Obstetric care providers should continue to receive training in all components of active management of the third stage of labor through training and education programs.

Clinical outcome analysis of modified B-Lynch sutures in the fundus uteri and part of the corpus uteri for the prevention of intraoperative haemorrhage during caesarean delivery in women with twin pregnancy: a retrospective study

ObjectiveTo explore the efficacy of modified B-Lynch sutures in the fundus uteri and part of the corpus uteri for the prevention of intraoperative haemorrhage during caesarean delivery in women with twin pregnancy.MethodsThis retrospective analysis covers the clinical data of 40 women with postpartum haemorrhage caused by uterine inertia during caesarean section in women with twin pregnancy in our hospital from January 2018 to May 2022. These women were divided into the group with modified B-Lynch sutures at the fundus and part of the corpus uteri (Group A, 20 patients) and the group with classic B-Lynch sutures (Group B, 20 patients) according to the treatment received. The treatment effect and safety of the two uterine compression sutures were compared.ResultsIn this study, no statistically significant differences were found in the outcomes of haemostasis or intraoperative and 24-h postoperative blood loss between the two uterine compression suture groups (P > 0.05). Compared to Group B, Group A showed a significantly reduced operative time, postoperative hospital stay, puerperal morbidity rate, pain score and duration of lochia.ConclusionModified B-Lynch sutures at the fundus and part of the corpus uteri can achieve a haemostatic effect similar to that of the classic B-Lynch suture, while it allows for a shortened operative time and reduced postoperative complications. Modified B-Lynch sutures can serve as a safe, rapid and effective haemostatic method for the prevention and treatment of postpartum haemorrhage during caesarean section in women with twin pregnancy, showing certain validity for promotion in clinics.

Role of Tranexamic Acid for Prevention of Postpartum Hemorrhage in Cesareans

Role of Tranexamic Acid for Prevention of Postpartum Hemorrhage in Cesareans

Postpartum haemorrhage in high-resource settings: Variations in clinical management and future research directions based on a comparative study of national guidelines.

To compare guidelines from eight high-income countries on prevention and management of postpartum haemorrhage (PPH), with a particular focus on severe PPH. Comparative study. High-resource countries. Women with PPH. Systematic comparison of guidance on PPH from eight high-income countries. Definition of PPH, prophylactic management, measurement of blood loss, initial PPH-management, second-line uterotonics, non-pharmacological management, resuscitation/transfusion management, organisation of care, quality/methodological rigour. Our study highlights areas where strong evidence is lacking. There is need for a universal definition of (severe) PPH. Consensus is required on how and when to quantify blood loss to identify PPH promptly. Future research may focus on timing and sequence of second-line uterotonics and non-pharmacological interventions and how these impact maternal outcome. Until more data are available, different transfusion strategies will be applied. The use of clear transfusion-protocols are nonetheless recommended to reduce delays in initiation. There is a need for a collaborative effort to develop standardised, evidence-based PPH guidelines. Definitions of (severe) PPH varied as to the applied cut-off of blood loss and incorporation of clinical parameters. Dose and mode of administration of prophylactic uterotonics and methods of blood loss measurement were heterogeneous. Recommendations on second-line uterotonics differed as to type and dose. Obstetric management diverged particularly regarding procedures for uterine atony. Recommendations on transfusion approaches varied with different thresholds for blood transfusion and supplementation of haemostatic agents. Quality of guidelines varied considerably.

An explorative analysis of pharmacovigilance data of oxytocin and its analogue carbetocin, with a focus on haemodynamic adverse effects

BackgroundOxytocin and its analogue carbetocin are uterotonics whose prophylactic use is recommended to prevent postpartum haemorrhage, which is one of the leading causes of maternal deaths worldwide. However, both drugs can cause specific adverse effects and haemodynamic challenges.AimThe aim of this work was to exploratively examine reports of adverse drug events of both drugs and to establish a comparative haemodynamic profile.MethodUsing data extracted from the World Health Organization’s pharmacovigilance database VigiBase, a descriptive analysis was performed of all reports for oxytocin and carbetocin as a suspected or interacting drug followed by a disproportionality analysis for haemodynamic events. Reporting odds ratios (ROR) of carbetocin for hypertension, hypotension, tachycardia, and bradycardia were calculated, with oxytocin-related reports serving as comparators.ResultsOxytocin and carbetocin were mentioned as suspected or interacting drugs in 11,258 and 374 reports, respectively. Resulting RORs for carbetocin were 3.45 (95%CI: 1.72–6.92) for hypertension, 2.65 (1.64–4.28) for hypotension, 2.84 (1.79–4.49) for tachycardia, and 2.00 (0.87–4.60) for bradycardia, when compared to oxytocin. Of 231 patients for whom oxytocin-related tachycardia was reported, 2.6% died, and of 91 patients for whom bradycardia was reported, 2.2% died. No deaths were reported with carbetocin for any of the haemodynamic adverse events.ConclusionCompared to oxytocin, carbetocin showed an elevated reporting for adverse hypertension, hypotension, and tachycardia in pharmacovigilance data. Clinicians should be aware of their patients' individual susceptibility and the possibility of haemodynamic deterioration until causal inferences are possible.

Effectiveness of Laqshya Guideline regarding Emergency Prevention and Management of Postpartum Haemorrhage (PPH) in Terms of Knowledge and Skills among Nursing Officers Working in Selected PHC & CHC and District Hospital of Gurugram

Effectiveness of Laqshya Guideline regarding Emergency Prevention and Management of Postpartum Haemorrhage (PPH) in Terms of Knowledge and Skills among Nursing Officers Working in Selected PHC & CHC and District Hospital of Gurugram

Tranexamic acid for the prevention of postpartum hemorrhage: a cost-effectiveness analysis.

Postpartum hemorrhage is a significant contributor to maternal mortality worldwide and in the United States. Tranexamic acid (TXA) has been shown to reduce PPH complications although it is not routinely recommended for use as prophylaxis to date. To estimate the cost-effectiveness of alternative risk-dictated strategies utilizing prophylactic tranexamic acid for the prevention of postpartum hemorrhage. We constructed a microsimulation-based Markov decision-analytic model estimating the cost-effectiveness of three alternative risk-dictated strategies for tranexamic acid prophylaxis versus the no prophylaxis in a cohort of 3.8 million pregnant women delivering in the United States. Each strategy differentially modified risk-specific hemorrhage probabilities by preliminary estimates of tranexamic acid's prophylactic efficacy. Outcome measures included incremental costs, quality-adjusted life-years, and outcomes averted. Costs and benefits were considered from the healthcare system and societal perspectives over a lifetime time horizon. All intervention strategies were dominant versus no prophylaxis, implying that they were simultaneously more effective and cost-saving. Prophylaxing delivering women irrespective of hemorrhage risk produced the most favorable results overall, with estimated cost savings greater than $690 million and up to 149,505 PPH cases, 2,933 hysterectomies, and 70 maternal deaths averted, per annual cohort. Threshold analysis suggested that tranexamic acid is likely to be cost-saving for health systems at costs below $190 per gram. Our findings suggest that routine prophylaxis with tranexamic acid would likely result in substantial cost-savings and reductions in adverse maternal outcomes in this context. This study is a cost-effectiveness analysis demonstrating cost-savings and reduction in adverse maternal outcomes with routine tranexamic acid as prophylaxis for post-partum hemorrhage.

Recent Trends in Tranexamic Acid Use During Postpartum Hemorrhage in the United States [ID: 1380480

INTRODUCTION: The United States has one of the highest rates of maternal mortality among developed regions, and postpartum hemorrhage (PPH) accounted for 14% of all pregnancy-related deaths between 2017 and 2019. Several large studies have demonstrated decreased PPH rates with the use of tranexamic acid (TXA). Consensus has not yet been reached on the when to administer use of TXA. Little data exist regarding the prevalence of TXA use in obstetric patients with and without PPH. METHODS: Using a national database, we identified over 1.2 million pregnancies between January 1, 2015, and June 30, 2021. Pregnancy and delivery information was abstracted using ICD-10 codes. The GW Institutional Review Board approved the study protocol and waived the requirement for patient informed consent. RESULTS: Overall, TXA was used 1% of the time (12,394/1,262,574), and there was a fivefold increase in TXA use (0.5–2.5%) during the study period. Patients had similar demographic characteristics. Tranexamic acid use differed by geographic region. The use of TXA increased in both patients with PPH and those without. There was a greater increase in the number of patients who received TXA for prophylaxis of PPH than those who received it as treatment of PPH. CONCLUSION: This is the largest U.S. observational study to examine patterns of TXA use in obstetrics. Tranexamic acid was only administered in approximately 10% (4,586/43,928) of cases of PPH. This represents an opportunity to increase awareness for the role of TXA in management and prevention of PPH.

Use of Tranexamic Acid for prevention of Postpartum hemorrhage after Cesarean section in high risk patients: A Randomized Controlled Trial

Use of Tranexamic Acid for prevention of Postpartum hemorrhage after Cesarean section in high risk patients: A Randomized Controlled Trial

Postpartum Hemorrhage Prevention Quality Improvement Initiatives and Blood Transfusion Utilization [ID: 1378079

INTRODUCTION: The universal implementation of active management of the third stage of labor, quantitative assessment of blood loss, and hemorrhage risk assessment on admission is recommended to reduce the incidence and morbidity of postpartum hemorrhage. We evaluated the effect of these quality improvement (QI) initiatives, in addition to an active management protocol for iron deficiency anemia antepartum, on the use of blood transfusion during delivery hospitalization. METHODS: We obtained blood transfusion data for the obstetric service at a tertiary care university hospital from January 1, 2017 to July 13, 2022, as well as data for every delivery during that time period (N=11,101). Institutional review board approval was obtained for the study. Patients whose transfusions were administered for nonobstetric indications were excluded. We compared the frequency of blood transfusions and number of units transfused per patient before and after the implementation of QI initiatives. RESULTS: There was a significant downward trend in the frequency of blood transfusions (P=.003) and the number of units transfused per patient (P=.000006) during the study period. The transfusion rate was 3.3% in the year prior to any intervention and 1.78% after implementation of all QI initiatives. No differences were observed in the characteristics of the patient population relevant to hemorrhage risk during the study period. CONCLUSION: This study provides evidence that in addition to reducing postpartum hemorrhage and its morbidity, these QI initiatives also help reduce blood transfusion utilization.

Prophylactic B-Lynch suture: efficacy in preventing postpartum hemorrhage in high-risk patients

Objective: To evaluate the effectiveness of prophylactic B-Lynch suture in the prevention of postpartum bleeding in patients at high risk for uterine atony, from the Concepción Palaces Maternity Delivery Room Service. Methods: Prospective, comparative and longitudinal study, which included 30 patients with risk factors for uterine atonia, randomly distributed in two groups: with and without B-Lynch compression suture. Echosonographic, clinical and paraclinical follow-up was performed at 12 and 24 hours after the postoperative period. A statistically significant contrast was considered if p < 0.05. Results: Haemoglobin reduction in patients with compressive suture was 0.5 ± 0.4 g/dl and hematocrit was 1.4 ± 1.1%; in the control group it was 1.6 ± 1.6 g/dl and 4 ± 4.7%, respectively (p-0.014/p-0.058). Bleeding at 12 and 24 hours was scarce in 73.3% and 93.3% of patients with compressive and moderate sutures or abundant in 100% and 93.4% of the control group (p-0.000). The reduction in the size of the uterus was greater in the experimental group than in the control group (p-0.000); 33.4% of patients with B-Lynch sutures and 93.4% without sutures had severe or unbearable pain at 12 hours (p-0.007) and at 24 hours there were no cases with severe or unbearable pain in the first group but in the second the frequency was 60%. Conclusions: Prophylactic B-Lynch suture is effective for preventing postpartum uterine atonia hemorrhage

Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section

BackgroundNeonatal health at delivery as measured by apgar scores is an important outcome. This study was done to assess the impact of anesthesia on Apgar 1-minute and 5-minute scores of infants delivered through elective cesarean section in Zimbabwe.MethodsWe carried out a secondary analysis of data from the Efficacy of Tranexamic Acid in Preventing Postpartum Hemorrhage (ETAPPH) clinical trial in Zimbabwe. Outcomes measured were infant Apgar scores at 1 and 5 min, exposure was the administration of either a general (intravenous propofol/ketamine/sodium thiopental) or spinal (hyperbaric bupivacaine 0.5%) anesthesia for anesthesia during the elective cesarean section procedure. Marginal Structural Logistic Modelling (MSM) using an unstabilized Inverse Probability Treatment Weight (IPTW) estimator was used to assess the relationship between anesthetic administration method and infant Apgar scores.ResultsFour hundred and twenty-one (421) women who had an elective caesarean section in the ETAPPH study had their infants assessed for Apgar scores. Comparing general anesthesia to spinal anesthesia, spinal anesthesia was related to good Apgar scores at 1-minute (adjusted odds ratio [aOR] = 4.0, 95% Confidence Interval = 1.5–10.7, sensitivity analysis E-value = 3.41). Spinal anesthetic administration was also related to good Apgar scores at 5 min (adjusted odds ratio [aOR] = 6.2, 95% Confidence Interval = 1.6–23.1, sensitivity analysis E-value = 4.42).ConclusionsWhen providing anesthesia for patients undergoing elective cesarean section, care should be taken on the method of administration of anesthetic agents. General anesthesia tends to depress Apgar scores at 1 min, although most neonates recover and have better scores at 5 min. Spinal anesthesia should be the first choice whenever possible.Trial registrationThe clinical trial from which data of this study was abstracted was registered under clinical trials registration number NCT04733157.

Active management of the third stage of labour in Ethiopia: A systematic review and meta-analysis.

Post-partum haemorrhage occurs in over 10% of all births and is the leading cause of maternal mortality, accounting for 25% of all maternal deaths worldwide. Active management of the third stage of labor is the most important intervention for reducing maternal morbidity and mortality by preventing postpartum hemorrhage. Previously, documented primary studies had been great discrepancy, inconsistent results, and there is a lack of comprehensive study. Hence, this systematic review and meta-analysis were intended to assess the prevalence and associated factors of the practice of active management of the third stage of labour among obstetric care providers in Ethiopia. Cross-sectional studies were systematically searched from January 01, 2010, to December 24, 2020, using PubMed, Google Scholar, HINARI, Cochrane Library, and grey literature. The pooled prevalence of active management of the third stage of labour practice and associated factors was estimated using DerSemonial-Laird Random Effect Model. Stata (version 16.0) was used to analyze the data. The I-squared statistic was used to assess the studies' heterogeneity. A funnel plot and Egger's test were used to check for publication bias. A subgroup analysis was performed to minimize the underline heterogeneity depending on the study years and the sample sizes. Seven hundred fifty articles were extracted. The final ten studies were included in this systematic review, including 2438 participants. The pooled prevalence of practices of active management of the third stage of labour among obstetric care providers in Ethiopia was 39.65% (30.86, 48.45%). Educational status (OR = 6.11, 95%CI, 1.51-10.72), obstetric care training (OR = 3.56, 95% CI: 2.66, 4.45), work experience (OR = 2.17, 95%CI, 0.47, 3.87) and knowledge of active management of the third stage of labour (OR = 4.5, 95% CI: 2.71, 6.28) were significantly associated with active management of the third stage of labour practices. The practice of active management of the third stage of labour in Ethiopia was low. This study showed that educational status, taking obstetric care training, knowledge of AMTSL, and work experience of obstetric care providers were associated with of practices of active management of the third stage of labour. Therefore, obstetric care professionals should improve their academic level, knowledge, and skills in order to provide useful service to AMTSL and save mothers' lives. All obstetric care providers should get obstetric care training. Furthermore, the government should increase obstetric care professionals' educational level.

Effect of Intravenous Tranxenamic Acid On Incidence of Postpartum Haemorrhage Among Parturients in Ekiti State

Post-partum haemorrhage (PPH) contributes to approximately 25% of maternal death globally. Tranexamic acid (TXA) has been confirmed to be effective in reducing post-partum blood loss, thereby preventing PPH and its possible sequelae. This clinical controlled trial compared the efficacy of a single dose of 0.5g of intravenous TXA to a single dose of 1g of intravenous TXA in prevention of primary PPH among high-risk parturient women in a teaching hospital. A total of 308 women served as the study sample; 154 women were randomly selected to be administered with 0.5g of tranexamic acid (study group), while the remaining 154 respondents were administered with 1g of tranexamic acid (control group). Post-partum blood loss was monitored immediately. All results were recorded in a proforma. Data were coded and entered into Statistical Package for the Social Sciences (SPSS) version 23. Continuous variables were presented as mean ± Standard deviation while categorical data such as frequency tables and percentages. Student’s t-test was used as appropriate for statistical significance. Results were considered statistically significant when P< 0.05. The mean blood loss of 475.79ml was higher in the study group compared to the mean blood loss of 430.18ml in the control group, this was statistically significant, (t=2.401, p<0.05). In conclusion, the 1g of tranexamic acid is more effective in the prevention of PPH compared to the 0.5g of tranexamic acid. It was recommended that 0.5g of tranexamic can be administered in the face of challenges at obtaining the standard 1g doses of tranexamic acid. However, the 1g standard dose of tranexamic acid is still the recommended dose especially for high-risk patients

Efficacy and Safety of Carbetocin in Prevention of Postpartum Hemorrhage

Objective: The study compared the effectiveness of carbetocin and oxytocin, administered post caesarian section for prevention of postpartum haemorrhage (PPH). Study Design: This was a prospective single center, case-control, cross sectional, observational, double ended study conducted from September 2020 to January 2022, comprising 150 female patients. Methods: The study was conducted at Hameeda Memorial Hospital Lahore in women undergoing caesarean section under regional and general anesthesia. Women were randomized to receive either carbetocin or oxytocin 5 IU intravenously. Results: Average age of patients was 34.5 years with average BMI of 27. It was noted that patients who were administered drugs had 348.6ml less blood loss than those not administered in PPH. Patients who did not received the drugs had average 800 ml blood loss. Whereas those who did had the drug had average of 451ml loss of bleed in PPH. Carbetocin showed effectiveness in preventing PPH by maintaining uterine tone. It was found that it significantly reduced the need for additional uterine contractile interventions to prevent or treat excessive bleeding after cesarean. In high-risk women, carbetocin has been found to be more effective than oxytocin in preventing blood loss greater than 500 mL during the cesarean section. Practical Implication: This study will help the gynecologists in selecting potent and safe therapeutic agents for the prevention of postpartum hemorrhages in high risk females. Conclusion: Carbetocin has been shown to be a safe and effective option for the prevention of postpartum hemorrhage in high-risk women as compared to other therapeutic agents along with potential safety margins. Keywords: Carbetocin, efficacy, safety, prevention, postpartum hemorrhage, oxytocin, uterotonic

Medical care for postpartum bleeding: A literature review

Relevance: According to modern literature, over the past decade, there has been no tendency in the world to reduce maternal mortality from postpartum hemorrhage (PPH). In Kazakhstan, evidence-based medicine clinical recommendations on prevention and algorithm of action for obstetric bleeding have been developed and recommended for use since 2010. We conducted a literary search for existing innovative methods of PPH prevention and treatment based on the study of clinical recommendations of many developed countries, WHO, FIGO, and scientific publications. There exist separate algorithms for managing PPH during vaginal delivery or cesarean section.The study aimed to explore the existing innovative methods of preventing and treating postpartum hemorrhage to determine the most effective medical care for postpartum hemorrhage.Materials and methods: The literature search included papers published on PubMed in English from January 1, 2018, to November 31, 2022. The search was done by keywords including “pregnancy,” “PPH,” “pregnancy complication,” “pregnancy outcomes,” and “tranexamic acid,” “guideline.” Results: Today, there are separate algorithms for managing PPH during vaginal delivery or cesarean section. Fibrin preparations and fibrinogen concentrate are recommended for use. When PPH occurs, it is important to communicate with family members to further inform them about the patient’s condition. The routine use of the Allgower shock index for accurate calculation of the volume of blood loss is proposed. It is proposed to use antifibrinolytic drugs not only for therapeutic purposes but also for prophylactic purposes. It is important to carry out adequate infusion-transfusion therapy to prevent iatrogenic coagulopathy. Conclusion: Introducing the above modern technologies into practical healthcare does not require high economic costs and can be used in obstetric institutions at all levels of medical care for PPH.

Comparative Study of Sublingual versus Rectal Route of Misoprostol Administration in Prevention of Primary Post-partum Haemorrhage in Women with Risk Factors in ESUT Teaching Hospital, Enugu, Nigeria

Background: Post-partum haemorrhage is a major cause of maternal death globally but more in low-income countries. While various studies recognized the efficacy of misoprostol in decreasing intraoperative blood loss, there is no consensus on the most effective route of administration of misoprostol. 
 Objective: This study compared the effect of sublingual misoprostol with rectal misoprostol in preventing primary post-partum haemorrhage in women with risk factor(s) to PPH. 
 Methodology: This is a comparative study that involved 200 participants who were randomized to two groups by 1:1 computer-based randomization (group A & group B). Each participant in group A received a 600mcg sublingual misoprostol plus rectal placebo, and participants in group B received a 600mcg rectal misoprostol plus sublingual placebo after delivery. The delivery mat already in use and soaked with liquor was removed once delivery was imminent, a new pre-weighed mat was replaced under the patient's buttocks, and also a pre-weighed sanitary pad was placed in her vulva to collect all the blood loss. The need for additional uterotonics and blood transfusion was assessed, and findings were documented appropriately in the proforma. Blood loss throughout a period of 24 hours after the delivery was measured by the gravimetric method. Weight gain from the sanitary pad/ delivery mat was calculated as 1g = 1 ml. The sanitary pad/mat was weighed in triplicate, and the mean of the three weights was entered into the database. The difference was the amount of blood loss, assuming 1g to be equivalent to 1 ml of blood. 
 Result: The median 24-hour post-partum blood loss was less in sublingual group when compared with the rectal group (110ml vs 170ml) P=0. 001.The mean post-partum Hb was higher in sublingual group 10.00±1.21 vs 9.00± 0.61 P=0.30. Both sublingual and rectal routes of misoprostol administration were effective in preventing PPH, P-value=1.0 and there was no indication for extra-uterotonic or blood transfusion.
 Conclusion: It is concluded that even though sublingually and rectally administered misoprostol showed equal efficacy in preventing PPH, sublingual route is associated with less blood loss.

Economic cost of secondary postpartum haemorrhage: A case-control study at a tertiary hospital in Australia.

Secondary postpartum haemorrhage (PPH) is a condition which affects 0.2-3.0% of women. Despite its impact on maternal morbidity, there is a lack of understanding of the cost burden of disease. To determine the economic cost of secondary PPH in the postpartum period, compared to the costs for women without this diagnosis. Data were prospectively collected on a cohort of 97 women who presented with secondary PPH to the emergency department (ED) between July 2020 and February 2021. A case-control design was then used to compare postpartum cost data from these patients to a group of 97 controls who were matched to maternal demographics, and who did not present with secondary PPH. For women with secondary PPH, there were significantly more hospital attendances, and postpartum costs were higher for all cost subcategories across ED, admissions, and outpatient attendances (P < 0.0001), compared to controls. The total cost of postpartum care for 97 patients with secondary PPH was $254 377.62 with an average cost per patient of $2622.45, compared to $26 670.46 for 97 controls with an average cost of $274.95 per patient (P < 0.0001). This demonstrates a 9.5-fold increase in postpartum costs per woman with secondary PPH. Secondary PPH is an under-researched condition which presents a significant cost burden for the health system. Evidence-based guidelines addressing the prevention and management of secondary PPH may assist in minimising this cost burden for both the health service and the patient.

Tranexamic acid for the prevention of postpartum haemorrhage: the TAPPH-1 pilot randomized trial and lessons learned for trials in Canadian obstetrics

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).