A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings.

The 3.1 target of the Sustainable Development Goals of the United Nations aims to reduce the global maternal mortality ratio to less than 70 maternal deaths per 100,000 live births by 2030. The last updates on this target show a significant stagnation in the data, thus reducing the chance of meeting it. What makes this negative result even more serious is that these maternal deaths could be avoided through prevention and the wider use of pharmacological strategies and devices to stop postpartum haemorrhage (PPH). PPH is the leading obstetric cause of maternal mortality in low- and middle-income countries (LMICs). Despite low-cost devices based on the uterine balloon tamponade (UBT) technique are already available, they are not safe enough to guarantee the complete stop of the bleeding. When effective, they are too expensive, especially for LMICs. To address this issue, this study presents the design, mechanical characterisation and technology assessment performed to validate a novel low-cost UBT kit, particularly a novel component, i.e., the connector, which guarantees the kit's effectiveness and represents the main novelty. Results proved the device's effectiveness in stopping PPH in a simulated scenario. Moreover, economic and manufacturing evaluations demonstrated its potential to be adopted in LMICs.

Especificidades técnicas no tamponamento uterino com balões e algumas dificuldades técnicas / Technical specificities in uterine tamponade with balloons and some technical difficulties

A mortalidade materna é inaceitavelmente alta. A hemorragia pós-parto encontra- se na primeira posição no mundo, tendo como principal causa específica a atonia uterina. Eventualmente, as medidas iniciais e a terapia farmacológica não são efetivas no controle do sangramento, impondo a necessidade de tratamentos invasivos, cirúrgicos ou não. Entre esses, o tamponamento uterino com balão requer recursos locais mínimos e não exige treinamento extensivo ou equipamento muito complexo. Entretanto, algumas dificuldades podem ocorrer durante a inserção, infusão ou manutenção do balão na cavidade uterina, com especificidades relacionadas à via de parto. Após o parto vaginal, a dificuldade mais prevalente é o prolapso vaginal do balão. Na cesárea, as principais dificuldades são a inserção e o posicionamento do balão na cavidade uterina, principalmente nas cesáreas eletivas. Este artigo revisa e ilustra as principais dificuldades e especificidades relacionadas ao tamponamento uterino com balões.

Maternal mortality is unacceptably high. Postpartum hemorrhage is ranked first in the world, with the main specific cause being uterine atony. Eventually, initial measures and pharmacological therapy are not effective in controlling bleeding, imposing the need for invasive treatments, surgical or not. Among these, uterine balloon tamponade requires minimal local resources and does not require extensive training or very complex equipment. However, some difficulties may occur during insertion, infusion, or maintenance of the balloon in the uterine cavity, with specificities related to the mode of delivery. After vaginal delivery, the most prevalent difficulty is vaginal balloon prolapse. In cesarean section, the main difficulty is the insertion and positioning of the balloon in the uterine cavity, especially in elective cesarean sections. This article reviews and illustrates the main difficulties and specificities related to uterine balloon tamponade.

Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery.

BACKGROUND: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear. METHODS: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed. RESULTS: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups. CONCLUSIONS: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).

Association Between Surgeon Gender and Maternal Morbidity After Cesarean Delivery.

Importance: The stereotype that men perform surgery better than women is ancient. Surgeons have long been mainly men, but in recent decades an inversion has begun; the number of women surgeons is increasing, especially in obstetrics and gynecology. Studies outside obstetrics suggest that postoperative morbidity and mortality may be lower after surgery by women. Objective: To evaluate the association between surgeons' gender and the risks of maternal morbidity and postpartum hemorrhage (PPH) after cesarean deliveries. Design, Setting, and Participants: This prospective cohort study was based on data from the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial, a multicenter, randomized, placebo-controlled trial that took place from March 2018 through January 2020 (23 months). It aimed to investigate whether the administration of tranexamic acid plus a prophylactic uterotonic agent decreased PPH incidence after cesarean delivery compared with a uterotonic agent alone. Women having a cesarean delivery before or during labor at or after 34 weeks' gestation were recruited from 27 French maternity hospitals. Exposures: Self-reported gender (man or woman), assessed by a questionnaire immediately after delivery. Main Outcomes and Measures: The primary end point was the incidence of a composite maternal morbidity variable, and the secondary end point was the incidence of PPH (the primary outcome of the TRAAP2 trial), defined by a calculated estimated blood loss exceeding 1000 mL or transfusion by day 2. Results: Among 4244 women included, men surgeons performed 943 cesarean deliveries (22.2%) and women surgeons performed 3301 (77.8%). The rate of attending obstetricians was higher among men (441 of 929 [47.5%]) than women (687 of 3239 [21.2%]). The risk of maternal morbidity did not differ for men and women surgeons: 119 of 837 (14.2%) vs 476 of 2928 (16.3%) (adjusted risk ratio, 0.92 [95% CI, 0.77-1.13]). Interaction between surgeon gender and level of experience on the risk of maternal morbidity was not statistically significant. Similarly, the groups did not differ for PPH risk (adjusted risk ratio, 0.98 [95% CI, 0.85-1.13]). Conclusions and Relevance: Risks of postoperative maternal morbidity and of PPH exceeding 1000 mL or requiring transfusion by day 2 did not differ by the surgeon's gender.

Association of SARS-CoV-2 Infection With Serious Maternal Morbidity and Mortality From Obstetric Complications.

Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity. Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications. Design, Setting, and Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period. Exposures: SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity. Main Outcomes and Measures: The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth. Results: Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]). Conclusions and Relevance: Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications.

Risk factors for postpartum haemorrhage in the Northern Province of Rwanda: A case control study.

BACKGROUND: Postpartum haemorrhage (PPH) remains a major global burden contributing to high maternal mortality and morbidity rates. Assessment of PPH risk factors should be undertaken during antenatal, intrapartum and postpartum periods for timely prevention of maternal morbidity and mortality associated with PPH. The aim of this study is to investigate and model risk factors for primary PPH in Rwanda. METHODS: We conducted an observational case-control study of 430 (108 cases: 322 controls) pregnant women with gestational age of 32 weeks and above who gave birth in five selected health facilities of Rwanda between January and June 2020. By visual estimation of blood loss, cases of Primary PPH were women who changed the blood-soaked vaginal pads 2 times or more within the first hour after birth, or women requiring a blood transfusion for excessive bleeding after birth. Controls were randomly selected from all deliveries without primary PPH from the same source population. Poisson regression, a generalized linear model with a log link and a Poisson distribution was used to estimate the risk ratio of factors associated with PPH. RESULTS: The overall prevalence of primary PPH was 25.2%. Our findings for the following risk factors were: antepartum haemorrhage (RR 3.36, 95% CI 1.80-6.26, P<0.001); multiple pregnancy (RR 1.83; 95% CI 1.11-3.01, P = 0.02) and haemoglobin level <11 gr/dL (RR 1.51, 95% CI 1.00-2.30, P = 0.05). During the intrapartum and immediate postpartum period, the main causes of primary PPH were: uterine atony (RR 6.70, 95% CI 4.78-9.38, P<0.001), retained tissues (RR 4.32, 95% CI 2.87-6.51, P<0.001); and lacerations of genital organs after birth (RR 2.14, 95% CI 1.49-3.09, P<0.001). Coagulopathy was not prevalent in primary PPH. CONCLUSION: Based on our findings, uterine atony remains the foremost cause of primary PPH. As well as other established risk factors for PPH, antepartum haemorrhage and intra uterine fetal death should be included as risk factors in the development and validation of prediction models for PPH. Large scale studies are needed to investigate further potential PPH risk factors.

Maternal morbidity and mortality: an iceberg phenomenon.

OBJECTIVE: To apply the iceberg model, quantifying absolute and relative incidence, to the four main causes of maternal morbidity and mortality in Ireland: haemorrhage, hypertension, sepsis and thrombosis. DESIGN: Secondary analysis of national data on maternal morbidity and mortality. SETTING: Republic of Ireland. POPULATION OR SAMPLE: Approximately 715 000 maternities, 1 200 000 maternal hospitalisations, 2138 cases of severe maternal morbidity (SMM) and 54 maternal deaths. METHODS: Incidence rates and case-fatality ratios were calculated. MAIN OUTCOME MEASURES: Maternal death, SMM and hospitalisation. RESULTS: At the 'tip of the iceberg', the incidence of maternal death per 10 000 maternities was 0.09 (95% CI 0.03-0.20) due to thrombosis and 0.03 (95% CI 0-0.11) due to haemorrhage, hypertension disorders or sepsis. For one death due to thrombosis there were 35 cases of pulmonary embolism and 257 thrombosis hospitalisations. For one death due to eclampsia, there were 58 eclampsia cases, 13 040 hospitalisations with pre-existing hypertension and 40 781 hospitalisations with gestational hypertension. For one death due to pregnancy-related sepsis, there were 92 cases of septicaemic shock and 9005 hospitalisations with obstetric sepsis. For one maternal death due to haemorrhage, there were 1029 cases of major obstetric haemorrhage and 53 715 maternal hospitalisations with haemorrhage. For every 100 maternities, there were approximately 16 hospitalisations associated with haemorrhage, 12 associated with hypertension disorders, three with sepsis and 0.2 with thrombosis. CONCLUSIONS: Haemorrhage and hypertension disorders are leading causes of maternal morbidity in Ireland but they have very low case fatality. This indicates that these morbidities are managed effectively but their prevention requires more focus. TWEETABLE ABSTRACT: Study shows that haemorrhage and hypertension are main causes of #maternalmorbidity in Ireland. Timely interventions for #maternalhealth and focus on prevention of severe and non-severe morbidities are needed. @NPEC #maternityservices #clinicalaudit #qualityimprovement.

Condições potencialmente ameaçadoras à vida no ciclo gravídico-puerperal / Condiciones potencialmente amenazantes para la vida en el ciclo gravídico puerperal / Potentially life-threatening conditions determinants in pregnancy-puerperal cycle

ABSTRACT Objetivo: Descrever as principais condições potencialmente ameaçadoras à vida de mulheres durante o ciclo gravídico e puerperal e variáveis relacionadas a esses agravos. Método: Estudo do tipo documental, descritivo e quantitativo, realizado com prontuários de gestantes, parturientes e puérperas internadas em hospital de média complexidade, que apresentaram Condições Potencialmente Ameaçadoras à Vida (CPAV). Foram excluídos os de acesso impossibilitado por estarem sob judice. A amostra foi temporal e a análise univariada. Resultados: Inclui-se 181 prontuários. A maioria das condições ocorreu em mulheres de 16 a 34 anos de idade (61,3%), união estável (60,8%), pardas (31,5%), sem renda ocupacional (29,2%), multíparas (28,87%), com complicações no primeiro trimestre gestacional (32,6%). Verificaram-se a realização de um número insuficiente de consultas (13,8%), dados referentes ao pré-natal ignorados (68%). As principais CPAV foram as síndromes hemorrágicas (28,2%), hipertensivas (25,4%) e infecção (13,3%). Como desfecho, foram observados prevalência de aborto não especificado (22,1%), morte perinatal por doença infecciosa e parasitária da mãe (2,2%). Conclusão: As principais CPAV foram as síndromes hemorrágicas, hipertensivas e infecções. Como desfecho, foram observados alta hospitalar, aborto, referenciamento à UTI, morte perinatal e morte materna.

RESUMEN Objetivo: describir las principales condiciones potencialmente amenazantes para la vida de las mujeres durante el ciclo gravídico y puerperal, además de las variables relacionadas con estos agravios. Método: estudio del tipo documental, descriptivo y cuantitativo, realizado con registros médicos de gestantes, parturientes y puérperas internadas en hospital de mediana complejidad, que presentaron Condiciones Potencialmente Amenazantes a la Vida (CPAV). Se excluyeron los de acceso imposibilitado por estar bajo juicio. La muestra fue temporal y el análisis univariado. Resultados: se incluyen 181 registros médicos. La mayoría de las condiciones ocurrió en mujeres de 16 a 34 años de edad (61,3%), unión estable (60,8%), pardas (31,5%), sin ingreso ocupacional (29,2%), multíparas (28,87%), con complicaciones en el primer trimestre gestacional (32,6%). Se constató un número insuficiente de consultas (13,8 %), datos relativos al prenatal ignorados (68 %). Las principales CPAV fueron los trastornos hemorrágicos (28,2%), hipertensivos (25,4%) e infecciosos (13,3%). Como resultado, se observaron: prevalencia de aborto no especificado (22,1%), muerte perinatal por enfermedad infecciosa y parasitaria de la madre (2,2%). Conclusión: las principales CPAV fueron los trastornos hemorrágicos, hipertensivos e infecciones. Como resultado, se observó alta hospitalaria, aborto, referencia a la UCI, muerte perinatal y muerte materna.

ABSTRACT Objective: To describe the main conditions potentially threatening the lives of women during the pregnancy and puerperal cycle and variables related to these diseases. Method: Documentary, descriptive and quantitative study, conducted with medical records of pregnant women, women giving birth and puerperal women hospitalized in a hospital of medium complexity, who presented Potentially Life Threatening Conditions (PLTC). Those with access unable to be sob judice were excluded. The sample was temporal and the analysis was univariate. Results: This includes 181 medical records. Most conditions occurred in women aged 16 to 34 years (61.3%), stable union (60.8%), brown (31.5%), without occupational income (29.2%), multiparous (28.87%), with complications in the first gestational trimester (32.6%). There was an insufficient number of consultations (13.8%), data regarding prenatal care ignored (68%). The main CPAV were hemorrhagic syndromes (28.2%), hypertensive (25.4%) and infection (13.3%). As an outcome, we observed a prevalence of unspecified miscarriage (22.1%), perinatal death from infectious and parasitic disease of the mother (2.2%). Conclusion: The main CPAV were hemorrhagic, hypertensive and infections syndromes. As an outcome, hospital discharge, miscarriage, ICU referral, perinatal death and maternal death were observed.

Utilization of non-pneumatic anti-shock garment and associated factors for postpartum hemorrhage management among obstetric care providers in public health facilities of southern Ethiopia, 2020.

BACKGROUND: Delays in care have been recognized as a significant contributor to maternal mortality in low-resource settings. The non-pneumatic antishock garment is a low-cost first-aid device that can help women with obstetric haemorrhage survive these delays without long-term adverse effects. Extending professionals skills and the establishment of new technologies in basic healthcare facilities could harvest the enhancements in maternal outcomes necessary to meet the sustainable development goals. Thus, this study aims to assess utilization of non-pneumatic anti-shock garment to control complications of post-partum hemorrhage and associated factors among obstetric care providers in public health institutions of Southern Ethiopia, 2020. METHODS: A facility-based cross-sectional study was conducted among 412 obstetric health care providers from March 15 -June 30, 2020. A simple random sampling method was used to select the study participants. The data were collected through a pre-tested interviewer-administered questionnaire. A binary logistic regression model was used to identify determinants for the utilization of non-pneumatic antishock garment. STATA version 16 was used for data analysis. A P-value of < 0.05 was used to declare statistical significance. RESULTS: Overall, 48.5% (95%CI: 43.73, 53.48%) of the obstetric care providers had utilized Non pneumatic antishock garment for management of complications from postpartum hemorrhage. Training on Non pneumatic antishock garment (AOR = 2.92; 95% CI: 1.74, 4.92), working at hospital (AOR = 1.81; 95% CI: 1.04, 3.16), good knowledge about NASG (AOR = 1.997; 95%CI: 1.16, 3.42) and disagreed and neutral attitude on Non pneumatic antishock garment (AOR = 0.41; 95%CI: 0.24, 0.68), and (AOR = 0.39; 95% CI: 0.21, 0.73), respectively were significantly associated with obstetric care provider's utilization of Non-pneumatic antishock garment. CONCLUSIONS: In the current study, roughly half of the providers are using Non-pneumatic antishock garment for preventing complications from postpartum hemorrhage. Strategies and program initiatives should focus on strengthening in-service and continuous professional development training, thereby filling the knowledge and attitude gap among obstetric care providers. Health centers should be targeted in future programs for accessibility and utilization of non-pneumatic antishock garment.

Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India.

OBJECTIVE: Post-partum hemorrhage (PPH) is the leading direct cause of maternal mortality in India. Uterine balloon tamponade (UBT) is recommended for atonic PPH cases not responding to uterotonics. This study assessed cost-effectiveness of three UBT devices used in Indian public health settings. METHODS: A decision tree model was built to assess cost-effectiveness of Bakri-UBT and low-cost ESM-UBT alternatives as compared to the recommended standard of care i.e. condom-UBT intervention. A hypothetical annual cohort of women eligible for UBT intervention after experiencing atonic PPH in Indian public health facilities were evaluated for associated costs and outcomes over life-time horizon using a disaggregated societal perspective. Costs by undertaking primary costing and clinical parameters from published literature were used. Incremental cost per Disability Adjusted Life Years (DALY) averted, number of surgeries and maternal deaths with the interventions were estimated. An India specific willingness to pay threshold of INR 24,211 (USD 375) was used to evaluate cost-effectiveness. Detailed sensitivity analysis and expected value of information analysis was undertaken. RESULTS: ESM-UBT at base-case Incremental Cost-Effectiveness Ratio (ICER) of INR -2,412 (USD 37) per DALY averted is a cost-saving intervention i.e. is less expensive and more effective as compared to condom-UBT. Probabilistic sensitivity analysis however shows an error probability of 0.36, indicating a degree of uncertainty around model results. Bakri-UBT at an ICER value of INR -126,219 (USD -1,957) per DALY averted incurs higher incremental societal costs and is less effective as compared to condom-UBT. Hence, Bakri-UBT is not cost-effective. CONCLUSION: For atonic PPH management in India, condom-UBT offers better value as compared to Bakri-UBT. Given the limited clinical effectiveness evidence and uncertainty in sensitivity analysis, cost-saving result for ESM-UBT must be considered with caution. Future research may focus on generating high quality comparative clinical evidence for UBT devices to facilitate policy decision making.

Midwives' challenges in the management of postpartum haemorrhage at rural PHC facilities of Limpopo province, South Africa: an explorative study.

BACKGROUND: Postpartum haemorrhage is one of the causes of the rise in maternal mortality. Midwives' experiences related to postpartum haemorrhage (PPH) management remain unexplored, especially in Limpopo. The purpose of the study was to explore the challenges experienced by midwives in the management of women with PPH. METHODS: Qualitative research was conducted to explore the challenges experienced by midwives in the management of women with PPH. Midwives were sampled purposefully. Unstructured interviews were conducted on 18 midwives working at primary health care facilities. Data were analysed after data saturation. RESULTS: After data analysis, one theme emerged "challenges experienced by midwives managing women with PPH" and five subthemes, including: "difficulty experienced resulting in feelings of frustrations and confusion and lack of time and shortage of human resource inhibits guidelines consultation". CONCLUSION: The study findings revealed that midwives experienced difficulty when managing women with postpartum haemorrhage. For successful implementation of maternal health care guidelines, midwives should be capacitated through training, supported and supervised in order to execute PPH management with ease.

Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.

BACKGROUND: Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. METHODS: This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. RESULTS: Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). CONCLUSIONS: Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. TRIAL REGISTRATION: This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).

Barriers inhibiting effective detection and management of postpartum hemorrhage during facility-based births in Madagascar: findings from a qualitative study using a behavioral science lens.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries, and is the most common direct cause of maternal deaths in Madagascar. Studies in Madagascar and other low-income countries observe low provider adherence to recommended practices for PPH prevention and treatment. Our study addresses gaps in the literature by applying a behavioral science lens to identify barriers inhibiting facility-based providers' consistent following of PPH best practices in Madagascar. METHODS: In June 2019, we undertook a cross-sectional qualitative research study in peri-urban and rural areas of the Vatovavy-Fitovinany region of Madagascar. We conducted 47 in-depth interviews in 19 facilities and five communities, with facility-based healthcare providers, postpartum women, medical supervisors, community health volunteers, and traditional birth attendants, and conducted thematic analysis of the transcripts. RESULTS: We identified seven key behavioral insights representing a range of factors that may contribute to delays in appropriate PPH management in these settings. Findings suggest providers' perceived low risk of PPH may influence their compliance with best practices, subconsciously or explicitly, and lead them to undervalue the importance of PPH prevention and monitoring measures. Providers lack clear feedback on specific components of their performance, which ultimately inhibits continuous improvement of compliance with best practices. Providers demonstrate great resourcefulness while operating in a challenging context with limited equipment, supplies, and support; however, overcoming these challenges remains their foremost concern. This response to chronic scarcity is cognitively taxing and may ultimately affect clinical decision-making. CONCLUSIONS: Our study reveals how perception of low risk of PPH, limited feedback on compliance with best practices and consequences of current practices, and a context of scarcity may negatively affect provider decision-making and clinical practices. Behaviorally informed interventions, designed for specific contexts that care providers operate in, can help improve quality of care and health outcomes for women in labor and childbirth.

Uterotonics for prevention of postpartum haemorrhage: EN-BIRTH multi-country validation study.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of preventable maternal mortality worldwide. The World Health Organization (WHO) recommends uterotonic administration for every woman after birth to prevent PPH. There are no standardised data collected in large-scale measurement platforms. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) is an observational study to assess the validity of measurement of maternal and newborn indicators, and this paper reports findings regarding measurement of coverage and quality for uterotonics. METHODS: The EN-BIRTH study took place in five hospitals in Bangladesh, Nepal and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data. We compared observation data for uterotonics to routine hospital register-records and women's report at exit-interview survey. We analysed the coverage and quality gap for timing and dose of administration. The register design was evaluated against gap analyses and qualitative interview data assessing the barriers and enablers to data recording and use. RESULTS: Observed uterotonic coverage was high in all five hospitals (> 99%, 95% CI 98.7-99.8%). Survey-report underestimated coverage (79.5 to 91.7%). "Don't know" replies varied (2.1 to 14.4%) and were higher after caesarean (3.7 to 59.3%). Overall, there was low accuracy in survey data for details of uterotonic administration (type and timing). Register-recorded coverage varied in four hospitals capturing uterotonics in a specific column (21.6, 64.5, 97.6, 99.4%). The average coverage measurement gap was 18.1% for register-recorded and 6.0% for survey-reported coverage. Uterotonics were given to 15.9% of women within the "right time" (1 min) and 69.8% within 3 min. Women's report of knowing the purpose of uterotonics after birth ranged from 0.4 to 64.9% between hospitals. Enabling register design and adequate staffing were reported to improve routine recording. CONCLUSIONS: Routine registers have potential to track uterotonic coverage - register data were highly accurate in two EN-BIRTH hospitals, compared to consistently underestimated coverage by survey-report. Although uterotonic coverage was high, there were gaps in observed quality for timing and dose. Standardisation of register design and implementation could improve data quality and data flow from registers into health management information reporting systems, and requires further assessment.

Healthcare providers experiences of using uterine balloon tamponade (UBT) devices for the treatment of post-partum haemorrhage: A meta-synthesis of qualitative studies.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of maternal mortality and severe morbidity globally. When PPH cannot be controlled using standard medical treatments, uterine balloon tamponade (UBT) may be used to arrest bleeding. While UBT is used by healthcare providers in hospital settings internationally, their views and experiences have not been systematically explored. The aim of this review is to identify, appraise and synthesize available evidence about the views and experiences of healthcare providers using UBT to treat PPH. METHODS: Using a pre-determined search strategy, we searched MEDLINE, CINAHL, PsycINFO, EMBASE, LILACS, AJOL, and reference lists of eligible studies published 1996-2019, reporting qualitative data on the views and experiences of health professionals using UBT to treat PPH. Author findings were extracted and synthesised using techniques derived from thematic synthesis and confidence in the findings was assessed using GRADE-CERQual. RESULTS: Out of 89 studies we identified 5 that met our inclusion criteria. The studies were conducted in five low- and middle-income countries (LMICs) in Africa and reported on the use of simple UBT devices for the treatment of PPH. A variety of cadres (including midwives, medical officers and clinical officers) had experience with using UBTs and found them to be effective, convenient, easy to assemble and relatively inexpensive. Providers also suggested regular, hands-on training was necessary to maintain skills and highlighted the importance of community engagement in successful implementation. CONCLUSIONS: Providers felt that administration of a simple UBT device offered a practical and cost-effective approach to the treatment of uncontrolled PPH, especially in contexts where uterotonics were ineffective or unavailable or where access to surgery was not possible. The findings are limited by the relatively small number of studies contributing to the review and further research in other contexts is required to address wider acceptability and feasibility issues.

Goals for Collaborative Management of Obstetric Hemorrhage.

Hemorrhage remains a leading cause of preventable maternal morbidity and mortality worldwide and in the United States. Postpartum hemorrhage is the number one cause of severe morbidity during hospitalization for birth, despite hospital, state, and national initiatives. In addition, studies show that more than 90% of maternal deaths related to obstetric hemorrhage are preventable. This article reviews relevant physiologic changes of pregnancy that may have an impact on hemorrhage management and describes collaborative approaches for management of hemorrhage in this unique population.

Health system and quality of care factors contributing to maternal deaths in East Java, Indonesia.

Despite most Indonesian women now receiving antenatal care on the nationally recommended four occasions and being delivered by skilled birth attendants, the nation's maternal mortality ratio (MMR) is estimated as 177 per 100,000 live births. Recent research in a rural district of Indonesia has indicated that poor service quality due to organizational and personnel factors is now a major determinant of this high MMR. The present research is an in-depth analysis of possible health service organizational and quality of care related causes of death among 30 women admitted to a peak referral hospital in a major Indonesian city. Despite their condition being complex or deteriorating, most of these women arrived at the hospital in a state where it was feasible to prevent death with good quality care. Poor application of protocols, poor information flow from frontline hospitals to the peak referral hospital, delays in emergency care, and delays in management of deteriorating patients were the main contributing factors to these deaths. Pyramidal referrals also contributed, as many women were initially referred to hospitals where their condition could not be effectively managed. While generic quality improvement measures, particularly training and monitoring for rigorous application of clinical protocols (including forward planning for deteriorating patients) will help improve the situation, the districts and hospitals need to develop capacity to assess their local situation. Unless local organisational factors, staff knowledge and skill, blood and blood product availability, and local reasons for delays in providing care are identified, it may not be possible to effectively reduce the adverse pregnancy outcomes.

Practical approach to transfusion management of post-partum haemorrhage.

OBJECTIVES: To describe transfusion management during post-partum haemorrhage (PPH) and the usefulness of standard or point-of-care (POC) laboratory tests for guiding haemostatic management. BACKGROUND: PPH is the leading cause of maternal mortality and severe maternal morbidity worldwide. Despite the efforts made in recent years, PPH is often burdened by preventable death. Recent data from the active Italian Obstetric Surveillance System (ItOSS) highlighted the following main critical issues: inadequate communication between healthcare professionals, inability to correctly and promptly assess the severity of haemorrhage, delays in diagnosis and treatment, failure to request blood promptly and inappropriate monitoring post-partum. MATERIALS AND METHODS: Data in the literature have been compared with the rotational thromboelastometry (ROTEM)- and the thromboelastography (TEG)-guided algorithms applied in the authors' departments. RESULTS: PPH transfusion therapy may have an empirical approach based on the standard use of blood products or a targeted approach based on coagulation monitoring by laboratory or POC tests. Here, the authors describe how they manage PPH in their departments, according to the Italian guidelines, along with the addition of a ROTEM- and a TEG-guided algorithms developed by themselves. CONCLUSION: Although the proposed algorithms have not been validated by trials or observational studies conducted in our departments, we believe that these indications could be useful for supporting clinical practice. Furthermore, we deem it appropriate to emphasise the importance of a multidisciplinary approach and the need for standardised and shared protocols to support the decisions of healthcare professionals.