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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. [ABSTRACT FROM AUTHOR]

Objective: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care. Methods: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Conclusion: Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014–004445-26. Date of registration 14 August 2014 Plain English summary: Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding. [ABSTRACT FROM AUTHOR]

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth.Methods/design: Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding margin, non-inferiority will have been demonstrated. The safety analysis will include all women receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing with significance levels for between-group comparisons.Discussion: If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide.Trial Registration: ACTRN12614000870651 (14 August 2014). [ABSTRACT FROM AUTHOR]

Background: The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60-70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. Objective: The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. Methods: A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour. The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000 ml or more at one hour and up to two hours for women who continue to bleed after one hour. The secondary outcomes are blood transfusion, the use of additional uterotonics and measure of severe morbidity and maternal death. We aim to recruit 25,000 women delivering vaginally in health facilities in eight countries within a 12 month recruitment period. Management: Overall trial management will be from HRP/RHR in Geneva. There will be eight centres located in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda. There will be an online data entry system managed from HRP/RHR. The trial protocol was developed following a technical consultation with international organizations and leading researchers in the field. Expected outcomes: The main objective of this trial is to investigate whether a simplified package of third stage management can be recommended without increasing the risk of PPH. By avoiding the need for a manual procedure that requires training, the third stage management can be implemented in a more widespread and cost-effective way around the world even at the most peripheral levels of the health care system. This trial forms part of the programme of work to reduce maternal deaths due to postpartum haemorrhage within the RHR department in collaboration with other research groups and organizations active in the field. [ABSTRACT FROM AUTHOR]

Background: The loss of large amounts of blood postpartum can lead to severe maternal morbidity and mortality. Understanding the nature of postpartum blood loss distribution is critical for the development of efficient analysis techniques when comparing treatments to prevent this event. When blood loss is measured, resulting in a continuous volume measure, often this variable is categorized in classes, and reduced to an indicator of volume greater than a cutoff point. This reduction of volume to classes entails a substantial loss of information. As a consequence, very large trials are needed to assess clinically important differences between treatments to prevent postpartum haemorrhage. Methods: The authors explore the nature of postpartum blood loss distribution, assuming that the physical properties of blood loss lead to a lognormal distribution. Data from four clinical trials and one observational study are used to confirm this empirically. Estimates of probabilities of postpartum haemorrhage events 'blood loss greater than a cutoff point' and relative risks are obtained from the fitted lognormal distributions. Confidence intervals for relative risk are obtained by bootstrap techniques. Results: A variant of the lognormal distribution, the three-parameter lognormal distribution, showed an excellent fit to postpartum blood loss data of the four trials and the observational study. A measurement quality assessment showed that problems of digit preference and lower limit of detection were well handled by the lognormal fit. The analysis of postpartum haemorrhage events based on a lognormal distribution improved the efficiency of the estimates. Sample size calculation for a hypothetical future trial showed that the application of this procedure permits a reduction of sample size for treatment comparison. Conclusion: A variant of the lognormal distribution fitted very well postpartum blood loss data from different geographical areas, suggesting that the lognormal distribution might fit postpartum blood loss universally. An approach of analysis of postpartum haemorrhage events based on the lognormal distribution improves efficiency of estimates of probabilities and relative risk, and permits a reduction of sample size for treatment comparison. Trial registration: This paper reports secondary analyses for trials registered at Australian New Zealand Clinical Trials Registry (ACTRN 12608000434392 and ACTRN12614000870651); and at clinicaltrials.gov (NCT00781066). [ABSTRACT FROM AUTHOR]

Background: Uterine tamponade is widely promoted for treating refractory postpartum hemorrhage (PPH); however, its cost‐effectiveness may vary depending on unit costs and setting. Objective: To review available data on cost‐effectiveness of uterine tamponade devices when used for PPH treatment. Search strategy: PubMed and EMBASE were searched (1980 to January 2020), as well as the National Health Services Economic Evaluation database from inception (1995) to March 2015. Selection criteria: Eligible studies were any type of economic evaluation, or effectiveness studies that provided cost or economic data. Data collection and analysis: Two reviewers independently screened studies, extracted data, and assessed quality. Main results: Eleven studies using a range of devices (condom catheter, uterine suction devices, Bakri, Inpress, Ellavi) were identified. Cost of condom catheter devices or kits ranged from US$0.64 to US$6, whereas purpose‐designed device costs were up to US$400. Two studies that took a health system perspective assessed the cost‐effectiveness of using uterine balloon tamponade and suggested that it was highly cost‐effective because of the low cost per disability‐adjusted life‐year averted, although both used effect estimates from case series. Conclusions: Evidence on the cost‐effectiveness of uterine tamponade devices was limited and not generalizable. Rigorous economic evaluations based on updated effect estimates are needed. Synopsis: Evidence on the cost‐effectiveness of uterine tamponade devices was limited and further economic evaluations based on updated effect estimates are needed. [ABSTRACT FROM AUTHOR]