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Timely detection and treatment of postpartum hemorrhage (PPH) are crucial to prevent complications or death. A calibrated blood-collection drape can help provide objective, accurate and early diagnosis of PPH, and a treatment bundle can address delays or inconsistencies in the use of effective interventions. Here we conducted an economic evaluation alongside the E-MOTIVE trial, an international, parallel cluster-randomized trial with a baseline control phase involving 210,132 women undergoing vaginal delivery across 78 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania. We aimed to assess the cost-effectiveness of the E-MOTIVE intervention, which included a calibrated blood-collection drape for early detection of PPH and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation), compared with usual care. We used multilevel modeling to estimate incremental cost-effectiveness ratios from the perspective of the public healthcare system for outcomes of cost per severe PPH (blood loss ≥1,000 ml) avoided and cost per disability-adjusted life-year averted. Our findings suggest that the use of a calibrated blood-collection drape for early detection of PPH and bundled first-response treatment is cost-effective and should be perceived by decision-makers as a worthwhile use of healthcare budgets. ClinicalTrials.gov identifier: NCT04341662 . An economic evaluation of the E-MOTIVE intervention for postpartum hemorrhage (PPH) compared with usual care in 210,132 women, carried out from a healthcare system perspective, uncovered the cost per case of severe PPH prevented and cost per disability-adjusted life-year averted.

IntroductionExcessive bleeding after childbirth (postpartum haemorrhage, PPH) affects 5% of births and causes 75 000 maternal deaths worldwide annually. It is the leading cause of direct maternal deaths globally and continues to be a major cause of mortality in the UK. Oxytocin is the standard first-line treatment for atonic PPH. The PPH rate is increasing, and this may be partially related to the overuse of oxytocics in labour. Laboratory studies on myometrium suggest that repeated use of oxytocics leads to the saturation of oxytocin receptors and reduced therapeutic efficacy of oxytocin. Carboprost (a prostaglandin analogue) is usually reserved for second-line management of atonic PPH. A systematic review comparing the efficacy of carboprost and conventional uterotonics for PPH prophylaxis found that carboprost was associated with less blood loss, but around 15% of women experienced side effects. The study’s aim is to compare intramuscular carboprost with intravenous oxytocin for the initial treatment of PPH. In addition, to assess the cost-effectiveness of both treatments, participants’ views on the two treatments and the consent process.Methods and analysisCOPE is a double-blind, double-dummy, randomised controlled trial that aims to recruit 2000 women (1:1 allocation, stratified by mode of birth) across 20 hospitals in the UK. Due to the emergency nature of PPH, COPE uses a research without prior consent (RWPC) model. Randomisation and treatment will occur if eligibility criteria are met once bleeding starts. Postnatal consent will be sought for disclosure of identifiable data and continued follow-up. Clinical efficacy outcomes will be collected at 24 and 48 hours or at hospital discharge, if sooner. Questionnaires will also be collected at 24 hours and 4 weeks postrandomisation. Cost-effectiveness will be based on the incremental cost per quality-adjusted life-year, calculated from the perspective of the NHS and personal social services.Ethics and disseminationThis study has been approved by the Coventry and Warwickshire Research Ethics Committee (REC) (18/WM/0227) and the Health Research Authority. Results will be disseminated via peer-reviewed publications.Trial registration numberISRCTN16416766.

Background Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness. Methods/Design We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women’s preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome. Discussion Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines. Trial registration The Netherlands Trial Register NTR3466

Background Maternal mortality due to postpartum hemorrhage (PPH) remains a global concern especially in low- and lower-middle income countries. PPH is preventable with quality-assured uterotonics. However, substandard uterotonics pose a significant risk to PPH, and there is limited evidence available to provide quantitative estimates of their economic impact. This study aims to evaluate the impact of ensuring uterotonic quality in Senegal, highlighting the potential to lower healthcare costs, reduce maternal deaths, and contribute to achieving Sustainable Development Goals related to maternal health and Universal Healthcare Coverage. Methods We utilized a decision tree model to estimate the economic and health impact of improving the quality of uterotonics in prevention of PPH in Senegal. We simulated women giving birth in various healthcare settings, receiving uterotonics of varied quality, and subsequent PPH-related outcomes. Data from the Senegal Demographic and Health Survey, Cochrane review, and E-MOTIVE trial informed the model. We compared scenarios with and without substandard uterotonics, along with scenarios altering uterotonic usage and care-seeking behavior. Results Our findings indicate that utilizing quality-assured uterotonics in Senegal could lead to a notable 7–9% reduction in the overall economic burden of PPH, saving over 1 million USD annually in direct costs and long-term productivity losses. Improving the quality of uterotonics in Senegal would result in a 6–8% reduction in PPH cases, translating to over 5,000 fewer PPH cases annually. Using quality uterotonics instead of substandard ones also decreased deaths from PPH by 6–8% annually. Conclusions This study underscores the importance of ensuring uterotonic quality to showcase significant cost savings and improvements in maternal health outcomes in Senegal. The accrued cost savings from improved maternal health outcomes related to PPH prevention and treatment would greatly benefit mothers, their families, healthcare providers, and the healthcare system. This case study offers valuable insights into improving the quality of maternal care and achieving more efficient resource allocation to advance Senegal’s progress towards Universal Health Coverage.

ObjectivesThe aim was to assess point-in-time stock availability and pricing of drugs used for postpartum haemorrhage management (oxytocin, misoprostol, heat-stable carbetocin and tranexamic acid (TXA)).DesignCross-sectional point-in-time survey using an adapted version of the WHO/Health Action International methodology.SettingIn public, for-profit and not-for-profit private health facilities and in pharmacies in the Democratic Republic of the Congo (DRC), India and Kenya.Participants211 health facilities in the DRC (n=63), India (n=76) and Kenya (n=72).Primary and secondary outcome measuresAvailability was calculated as a mean percentage of facility types where each medicine was observed on the day of data collection. Average procurement prices were calculated by obtaining the current purchase price per drug at each facility and then averaging prices across all facility types.ResultsAvailability of the four medicines was limited, and only oxytocin in the DRC met the WHO’s benchmark of 80%. Across all countries, availability of oxytocin, misoprostol and TXA was lower in public health facilities than in other facility types, indicating an important gap. Where the four medicines were available, non-quality-assured products were predominant across the three countries. The average facility procurement prices in India and Kenya were reported to be lower than those in the DRC.ConclusionsAvailability of oxytocin, misoprostol, heat-stable carbetocin and TXA was suboptimal and varied by facility type and geography, and similar trends were found across the four drugs. This indicates that access strategies should be tailored to each drug, geographical area and facility type. Strategies to improve commodity access in public-sector facilities will be especially important, as well as improving the availability of quality-assured products, possibly through value-based procurement practices.

Background Uterotonics are essential in reducing the risk of postpartum haemorrhage (PPH) and saving mothers’ lives. However, numerous quality-testing studies have found that uterotonics in many low- and middle-income countries are substandard. This study compares the economic, health, and policy implications of poor-quality uterotonics in three West African countries: Ghana, Nigeria, and Senegal. The economic impact of poor-quality uterotonics has not been previously compared. Methods We utilized a decision-tree model to examine the implications of using substandard uterotonics (oxytocin and misoprostol) in three countries. The model simulated the place and mode of delivery, use and quality of uterotonics, risk and diagnosis of PPH and resulting economic and health outcomes. Country-specific inputs were derived from demographic and health surveys and published literature. Given large variations in population size, results were compared across 100 000 women giving birth. Results Ghana demonstrated the greatest benefit from improvements in uterotonic quality, with US $2 million (13%) in annual cost savings and 2200 (11%) cases of PPH avoided per 100 000 women giving birth. Comparatively, annual cost savings were estimated at US $1.1 million (7%) and US $224,000 (7%) per 100 000 birthing women in Nigeria and Senegal, respectively. The yearly reduction in PPH cases per 100 000 birthing women was projected at 875 (6%) for Senegal and 944 (4%) for Nigeria. Taking varying population sizes into account, we saw that improvement in uterotonic quality could annually save US $89 million in Nigeria, US $18.8 million in Ghana and US $1.3 million in Senegal, leading to 100 000 fewer PPH cases per year overall. These simulated results were primarily driven by high proportions of substandard uterotonics and high facility use in Ghana, high numbers of home births in Nigeria and substandard misoprostol use in Senegal. Conclusions Improving uterotonic quality would bring significant cost savings and maternal health improvements across countries. Specific policies to improve uterotonic quality and bring about the economic and health benefits may need to be tailored by country. Ensuring the quality of uterotonics is essential in improving medicine equity and would contribute towards efforts to achieve universal health coverage by ensuring that medications adequately achieve their value for money.

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.

In settings where home birth rates are high, prenatal distribution of misoprostol has been advocated as a strategy to increase access to uterotonics during the third stage of labor to prevent postpartum hemorrhage (PPH). Our objective was to project the potential cost-effectiveness of this strategy in Uganda from both governmental (the relevant payer) and modified societal perspectives. To compare prenatal misoprostol distribution to status quo (no misoprostol distribution), we developed a decision analytic model that tracked the delivery pathways of a cohort of pregnant women from the prenatal period, labor to delivery without complications or delivery with PPH, and successful treatment or death. Delivery pathway parameters were derived from the Uganda Demographic and Health Survey. Incidence of PPH, treatment efficacy, adverse event and case fatality rates, access to misoprostol, and health resource use and cost data were obtained from published literature and supplemented with expert opinion where necessary. We computed the expected incidence of PPH, mortality, disability adjusted life years (DALYs), costs and incremental cost effectiveness ratios (ICERs). We conducted univariate and probabilistic sensitivity analyses to examine robustness of our results. In the base-case analysis, misoprostol distribution lowered the expected incidence of PPH by 1.2% (95% credibility interval (CrI): 0.55%, 1.95%), mortality by 0.08% (95% CrI: 0.04%, 0.13%) and DALYs by 0.02 (95% CrI: 0.01, 0.03).” and “ICERs were US$181 (95% CrI: 81, 443) per DALY averted from a governmental perspective, and US$64 (95% CrI: -84, 260) per DALY averted from a modified societal perspective [corrected]. Prenatal distribution of misoprostol is potentially cost-effective in Uganda and should be considered for national-level scale up for prevention of PPH.

ObjectiveTo evaluate the costs associated with induction of labour in intrauterine growth restriction fetuses comparing different procedures.Study design150 pregnancies at term diagnosed with intrauterine growth restriction and indication for induction of labour were included. 24 were ripened with misoprostol 25 μg tablets, 24 with dinoprostone 10 mg vaginal insert, and 77 with Cook® cervical ripening balloon. To determine the costs of induction of labour, method of induction, intrapartum medication, epidural analgesia, type of delivery, and maternal and neonatal admissions were considered. Statistical analysis was performed using the G-Stat 2.0 free statistical software. ANOVA test was used for comparisons between quantitative parametric variables. Chi-squared test or Fisher test was used for qualitative variables. A value of p < 0.05 was considered statistically significant.ResultsUp to 70.83% women in dinoprostone group gave birth within the first 24 h compared to 42.66% in misoprostol group and 36.36% in CG (p < 0.01). Misoprostol tablets were cheaper (9.45 ± 1.52 US dollars) than dinoprostone or Cook® balloon (41.67 ± 0 and 59.85 ± 0 54.45 ± 0 US dollars, respectively) (p < 0.01). Costs related to maternal admissions were higher in CG (475.13 ± 146.95$) than dinoprostone group (475.13 ± 146.95$) or MG (427.97 ± 112.65$) (p = 0.03). Total costs in misoprostol group (2765.18 ± 495.38$) were lower than in the dinoprostone group (3075.774 ± 896.14$) or Cook® balloon group (3228.02 ± 902.06$) groups.ConclusionsMisoprostol for induction of labour had lower related costs than dinoprostone or Cook® balloon, with similar obstetrical and perinatal outcomes.

Background While inferior to oxytocin injection in both efficacy and safety, orally administered misoprostol has been included in the World Health Organization Model List of Essential Medicines for use in the prevention of postpartum haemorrhage (PPH) in low-resource settings. This study evaluates the costs and health outcomes of use of oral misoprostol to prevent PPH in settings where injectable uterotonics are not available. Methods A cost-consequences analysis was conducted from the international health system perspective, using data from a recent Cochrane systematic review and WHO’s Mother-Baby Package Costing Spreadsheet in a hypothetical cohort of 1000 births in a mixed hospital (40 % births)/community setting (60 % births). Costs were estimated based on 2012 US dollars. Results Using oxytocin in the hospital setting and misoprostol in the community setting in a cohort of 1000 births, instead of oxytocin (hospital setting) and no treatment (community setting), 22 cases of PPH could be prevented. Six fewer women would require additional uterotonics and four fewer women a blood transfusion. An additional 130 women would experience shivering and an extra 42 women fever. Oxytocin/misoprostol was found to be cost saving (US$320) compared to oxytocin/no treatment. If misoprostol is used in both the hospital and community setting compared with no treatment (i.e. oxytocin not available in the hospital setting), 37 cases of PPH could be prevented; ten fewer women would require additional uterotonics; and six fewer women a blood transfusion. An additional 217 women would experience shivering and 70 fever. The cost savings would be US$533. Sensitivity analyses indicate that the results are sensitive to the incidence of PPH-related outcomes, drug costs and the proportion of hospital births. Conclusions Our findings confirm that, even though misoprostol is not the optimum choice in the prevention of PPH, misoprostol could be an effective and cost-saving choice where oxytocin is not or cannot be used due to a lack of skilled birth attendants, inadequate transport and storage facilities or where a quality assured oxytocin product is not available. These benefits need to be weighed against the large number of additional side effects such as shivering and fever, which have been described as tolerable and of short duration.