There is a need for a clear and actionable definition of maternal sepsis, in order to better assess the burden of this condition, trigger timely and effective treatment and allow comparisons across ...facilities and countries. The objective of this study was to review maternal sepsis definitions and identification criteria and to report on the results of an expert consultation to develop a new international definition of maternal sepsis.
All original and review articles and WHO documents, as well as clinical guidelines providing definitions and/or identification criteria of maternal sepsis were included. A multidisciplinary international panel of experts was surveyed through an online consultation in March-April 2016 on their opinion on the existing sepsis definitions, including new definition of sepsis proposed for the adult population (2016 Third International Consensus Definitions for Sepsis and Septic Shock) and importance of different criteria for identification of maternal sepsis. The definition was agreed using an iterative process in an expert face-to-face consensus development meeting convened by WHO and Jhpiego.
Standardizing the definition of maternal sepsis and aligning it with the current understanding of sepsis in the adult population was considered a mandatory step to improve the assessment of the burden of maternal sepsis by the expert panel. The literature review and expert consultation resulted in a new WHO consensus definition "Maternal sepsis is a life-threatening condition defined as organ dysfunction resulting from infection during pregnancy, child-birth, post-abortion, or post-partum period". Plans are in progress to validate the new WHO definition of maternal sepsis in a large international population.
The operationalization of the new maternal sepsis definition requires generation of a set of practical criteria to identify women with sepsis. These criteria should enable clinicians to focus on the timely initiation of actionable elements of care (administration of antimicrobials and fluids, support of vital organ functions, and referral) and improve maternal outcomes.
Objective
To systematically develop evidence‐based bundles for care of postpartum hemorrhage (PPH).
Methods
An international technical consultation was conducted in 2017 to develop draft bundles of ...clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated “GRADE Evidence‐to‐Decision” framework. Twenty‐three global maternal‐health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6‐month period, the expert panel met online and via teleconferences, culminating in a 2‐day in‐person meeting.
Results
The consultation led to the definition of two care bundles for facility implementation. The “first response to PPH bundle” comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The “response to refractory PPH bundle” comprises compressive measures (aortic or bimanual uterine compression), the non‐pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements.
Conclusion
For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.
Care bundles were defined for first response and refractory PPH. Implementation strategies, refractory PPH definition, and effectiveness of intrauterine balloon tamponade require further consultation.
In the quest for quality antenatal care (ANC) and positive pregnancy experience, the value of comprehensive woman hand-held case notes cannot be emphasised enough. However, the woman's health ...passport book in Malawi presents gaps which hinder provision of quality care, especially during pregnancy. We aimed to develop a compressive updated woman hand-held case notes tool (health passport book) which reflects WHO 2016 ANC guidelines in Malawi.
From July 2022 to August 2022, we applied a co-creative participatory approach in 3 workshops with key stakeholders to compare the current ANC tool contents to the WHO 2016 ANC guidelines, decide on key elements to be changed to improve adherence and change in practice, and redesign the woman's health passport tool to reflect the changes. Within-group discussions led to whole-group discussions and consensus, guided by a modified nominal group technique. Facilitators guided the discussions while ensuring autonomy of the group members in their deliberations. Discussions were recorded and transcribed. Data was analysed through thematic analysis, and reduction and summaries in affinity diagrams. The developed tool was endorsed for implementation within Malawi's healthcare system by the national safe motherhood technical working group (TWG) in July 2023.
Five themes were identified in the analysis. These were (i) critical components in the current tool missed, (ii) reimagining the current ANC tool, (iii) opportunity for ultrasound scanning conduct and documentation, (iv) anticipated barriers related to implementation of the newly developed tool and (v) cultivating successful implementation. Participants further recommended strengthening of already existing policies and investments in health, strengthening public private partnerships, and continued capacity building of healthcare providers to ensure that their skill sets are up to date.
Achieving goals of quality ANC and universality of healthcare are possible if tools in practice reflect the guidelines set out. Our efforts reflect a pioneering attempt in Malawi to improve women's hand-held case notes, which we know help in enhancing quality of care and improve overall women's satisfaction with their healthcare system.
We used national facility-level data from all government hospitals in Malawi to examine the effects of the second and third COVID-19 waves on maternal and neonatal outcomes and access to care during ...September 6, 2020–October 31, 2021. The COVID-19 pandemic affected maternal and neonatal health not only through direct infections but also through disruption of the health system, which could have wider indirect effects on critical maternal and neonatal outcomes. In an interrupted time series analysis, we noted a cumulative 15.4% relative increase (63 more deaths) in maternal deaths than anticipated across the 2 COVID-19 waves. We observed a 41% decrease in postnatal care visits at the onset of the second COVID-19 wave and 0.2% by the third wave, cumulative to 36,809 fewer visits than anticipated. Our findings demonstrate the need for strengthening health systems, particularly in resource-constrained settings, to prepare for future pandemic threats.
The World Health Organization and partners developed and evaluated a maternity-specific sepsis care bundle called 'FAST-M' for low-resource settings. However, this bundle has not yet been studied in ...Asia. Our study sought to evaluate the perceptions of healthcare providers about the implementation of the FAST-M intervention in Pakistan.
The study was conducted at a public sector hospital in Hyderabad. We conducted three focus group discussions with healthcare providers including doctors, nurses, and healthcare administrators (n = 22) who implemented the FAST-M intervention. The Consolidated Framework for Implementation Research was used as a guiding framework for data collection and analysis. The data were analyzed using a thematic analysis approach and deductive methods.
Five overarching themes emerged: (I) FAST-M intervention and its significance including HCPs believing in the advantages of using the intervention to improve clinical practices; (II) Influence of outer and inner settings including non-availability of resources in the facility for sepsis care; (III) HCPs perceptions about sustainability, which were positive (IV) Integration into the clinical setting including HCPs views on the existing gaps, for example, shortage of HCPs and communication gaps, and their recommendations to improve these; and (V) Outcomes of the intervention including improved clinical processes and outcomes using the FAST-M intervention. Significant improvement in patient monitoring and FAST-M bundle completion within an hour of diagnosis of sepsis was reported by the HCPs.
The healthcare providers' views were positive about the intervention, its outcomes, and long-term sustainability. The qualitative data provided findings on the acceptability of the overall implementation processes to support subsequent scaling up of the intervention.
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic drugs can reduce blood loss and are routinely recommended. There are several uterotonic ...drugs for preventing PPH, but it is still debatable which drug or combination of drugs is the most effective.
To identify the most effective and cost-effective uterotonic drug(s) to prevent PPH, and generate a ranking according to their effectiveness and side-effect profile.
The Cochrane Pregnancy and Childbirth's Trials Register (1 June 2015), ClinicalTrials.gov and the World Health Organization (WHO)'s International Clinical Trials Registry Platform (ICTRP) were searched for unpublished trial reports (30 June 2015). In addition, reference lists of retrieved studies (updated October 2017) were searched for randomised trials evaluating uterotonic drugs for preventing PPH. The study estimated relative effects and rankings for preventing PPH, defined as blood loss of ≥ 500 ml and ≥ 1000 ml. Pairwise meta-analyses and network meta-analysis were performed to determine the relative effects and rankings of all available drugs and combinations thereof ergometrine, misoprostol (Cytotec
; Pfizer Inc., New York, NY, USA), misoprostol plus oxytocin (Syntocinon
; Novartis International AG, Basel, Switzerland), carbetocin (Pabal
; Ferring Pharmaceuticals, Saint-Prex, Switzerland), ergometrine plus oxytocin (Syntometrine
; Alliance Pharma plc, Chippenham, UK), oxytocin, and a placebo or no treatment. Primary outcomes were stratified according to the mode of birth, prior risk of PPH, health-care setting, drug dosage, regimen and route of drug administration. Sensitivity analyses were performed according to study quality and funding source, among others. A model-based economic evaluation compared the relative cost-effectiveness separately for vaginal births and caesareans with or without including side effects.
From 137 randomised trials and 87,466 women, ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin were found to reduce the risk of PPH blood loss of ≥ 500 ml compared with the standard drug, oxytocin ergometrine plus oxytocin: risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.83; carbetocin: RR 0.72, 95% CI 0.52 to 1.00; misoprostol plus oxytocin: RR 0.73, 95% CI 0.6 to 0.9. Each of these three strategies had 100% cumulative probability of being ranked first, second or third most effective. Oxytocin was ranked fourth, with an almost 0% cumulative probability of being ranked in the top three. Similar rankings were noted for the reduction of PPH blood loss of ≥ 1000 ml (ergometrine plus oxytocin: RR 0.77, 95% CI 0.61 to 0.95; carbetocin: RR 0.70, 95% CI 0.38 to 1.28; misoprostol plus oxytocin: RR 0.90, 95% CI 0.72 to 1.14), and most secondary outcomes. Ergometrine plus oxytocin and misoprostol plus oxytocin had the poorest ranking for side effects. Carbetocin had a favourable side-effect profile, which was similar to oxytocin. However, the analysis was restricted to high-quality studies, carbetocin lost its ranking and was comparable to oxytocin. The relative cost-effectiveness of the alternative strategies is inconclusive, and the results are affected by both the uncertainty and inconsistency in the data reported on adverse events. For vaginal delivery, when assuming no adverse events, ergometrine plus oxytocin is less costly and more effective than all strategies except carbetocin. The strategy of carbetocin is both more effective and more costly than all other strategies. When taking adverse events into consideration, all prevention strategies, except oxytocin, are more costly and less effective than carbetocin. For delivery by caesarean section, with and without adverse events, the relative cost-effectiveness is different, again because of the uncertainty in the available data.
There was considerable uncertainty in findings within the planned subgroup analyses, and subgroup effects cannot be ruled out.
Ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin are more effective uterotonic drug strategies for preventing PPH than the current standard, oxytocin. Ergometrine plus oxytocin and misoprostol plus oxytocin cause significant side effects. Carbetocin has a favourable side-effect profile, which was similar to oxytocin. However, most carbetocin trials are small and of poor quality. There is a need for a large high-quality trial comparing carbetocin with oxytocin; such a trial is currently being conducted by the WHO. The relative cost-effectiveness is inconclusive, and results are affected by uncertainty and inconsistency in adverse events data.
This study is registered as PROSPERO CRD42015020005; Cochrane Pregnancy and Childbirth Group (substudy) reference number 0871; PROSPERO-Cochrane (substudy) reference number CRD42015026568; and sponsor reference number ERN_13-1414 (University of Birmingham, Birmingham, UK).
Funding for this study was provided by the National Institute for Health Research Health Technology Assessment programme in a research award to the University of Birmingham and supported by the UK charity Ammalife (UK-registered charity 1120236). The funders of the study had no role in study design, data collection, data synthesis, interpretation or writing of the report.
IntroductionStudies have shown that women are often underinformed about potential benefits and risks of vaginal birth. This is in contrast to other modes of birth, such as caesarean birth, for which ...the risks/benefits are often conveyed prior to undergoing the procedure. A core information set (CIS) is an agreed set of information points that should be discussed with all patients prior to undergoing a procedure or intervention. This CIS could improve the quality of information given regarding mode of birth options, as women will be given information prioritised by patients and stakeholders regarding vaginal birth, empowering them to make informed decisions about their birth. We aim to describe the protocol for the development of this vaginal birth CIS.Methods and analysisWe will develop the CIS by: (1) Compiling a ‘long-list’ of information points about vaginal birth by: undertaking a scoping review of studies and patient information leaflets; interviews with antenatal/postnatal women, an online survey of stakeholders. (2) Collating the ‘long-list’ of information points and developing the Delphi survey. Think-aloud interviews will refine the survey. (3) Conducting a two-round Delphi survey. 200 stakeholder participants will be recruited. Items rated critically important by ≥80% of participants in one stakeholder group, or with no consensus, will be carried through to a stakeholder consensus meeting to decide the final CIS. Planned start date is 1 June 2022. Planned end date is 31 August 2023.Ethics and disseminationThis project has been given a favourable ethics opinion by the University of Bristol Research Ethics Committee (Ref: 10530). Approval from the ethics committee will be sought for any protocol amendments, and the principal investigator will be responsible for these changes. Findings will be presented at relevant conferences and published in a high-impact journal. We will disseminate the CIS, via Policy Bristol, to clinical policy and guideline developers.
Objectives
Recombinant granulocyte colony‐stimulating factor (G‐CSF) is frequently administered to patients with cancer to enhance granulocyte recovery post‐chemotherapy. Clinical trials have also ...used G‐CSF to modulate myeloid cell function in pregnancy and inflammatory diseases. Although the contribution of G‐CSF to expanding normal granulocytes is well known, the effect of this cytokine on the phenotype and function of immunosuppressive granulocytic cells remains unclear. Here, we investigate the impact of physiological and iatrogenic G‐CSF on an as yet undescribed granulocyte phenotype and ensuing outcome on T cells in the settings of cancer and pregnancy.
Methods
Granulocytes from patients treated with recombinant G‐CSF, patients with late‐stage cancer and women enrolled on a trial of recombinant G‐CSF were phenotyped by flow cytometry. The ability and mechanism of polarised granulocytes to suppress T‐cell proliferation were assessed by cell proliferation assays, flow cytometry and ELISA.
Results
We observed that G‐CSF leads to a significant upregulation of CD14 expression on CD15+ granulocytes. These CD15+CD14+ cells are identified in the blood of patients with patients undergoing neutrophil mobilisation with recombinant G‐CSF, and physiologically in women early in pregnancy or in those treated as a part of a clinical trial. Immunohistochemistry of tumor tissue or placental tissue identified the expression of G‐CSF. The G‐CSF upregulates the release of reactive oxygen species (ROS) in CD15+CD14+ cells leading to the suppression of T‐cell proliferation.
Conclusions
G‐CSF induces a population of ROS+ immunosuppressive CD15+CD14+ granulocytes. Strategies for how recombinant G‐CSF can be scheduled to reduce effects on T‐cell therapies should be developed in future clinical studies.
G‐CSF physiologically drives granulocyte expansion and is also administered in recombinant form alongside chemotherapy or immunotherapy. We show that G‐CSF upregulates the release of reactive oxygen species (ROS) in a unique population of CD15+CD14+ cells leading to the suppression of T‐cell proliferation.
ObjectiveAccurate reporting of birth outcomes in low-income and middle-income countries (LMICs) is essential. Mobile health (mHealth) tools have been proposed as a replacement for conventional ...paper-based registers. mHealth could provide timely data for individual facilities and health departments, as well as capture deliveries outside facilities. This scoping review evaluates which mHealth tools have been reported to birth outcomes in the delivering room in LMICs and documents their reported advantages and drawbacks.DesignA scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Joanna Briggs Institute guidelines for scoping reviews and the mHealth evidence reporting and assessment checklist for evaluating mHealth interventions.Data sourcesPubMed, CINAHL and Global Health were searched for records until 3 February 2022 with no earliest date limit.Eligibility criteriaStudies were included where healthcare workers used mHealth tools in LMICs to record birth outcomes. Exclusion criteria included mHealth not being used at the point of delivery, non-peer reviewed literature and studies not written in English.Data extraction and synthesisTwo independent reviewers screened studies and extracted data. Common themes among studies were identified.Results640 records were screened, 21 of which met the inclusion criteria, describing 15 different mHealth tools. We identified six themes: (1) digital tools for labour monitoring (8 studies); (2) digital data collection of specific birth outcomes (3 studies); (3) digital technologies used in community settings (6 studies); (4) attitudes of healthcare workers (10 studies); (5) paper versus electronic data collection (3 studies) and (6) infrastructure, interoperability and sustainability (8 studies).ConclusionSeveral mHealth technologies are reported to have the capability to record birth outcomes at delivery, but none were identified that were designed solely for that purpose. Use of digital delivery registers appears feasible and acceptable to healthcare workers, but definitive evaluations are lacking. Further assessment of the sustainability of technologies and their ability to integrate with existing health information systems is needed.
Infection with vaginal microorganisms during labour can lead to maternal and neonatal mortality and morbidity. The objective of this systematic review is to review the effectiveness of intrapartum ...vaginal chlorhexidine in the reduction of maternal and neonatal colonisation and infectious morbidity.
Search strategy - Eight databases were searched for articles published in any language from inception to October 2016. Selection criteria - Randomised controlled trials were included. Data Collection and analysis - Publications were assessed for inclusion. Data were extracted and assessed for risk of bias. Relative risks from individual studies were pooled using a random effects model and the heterogeneity of treatment was evaluated using Chi
and I
tests.
Eleven randomised controlled trials (n = 20,101) evaluated intrapartum vaginal chlorhexidine interventions. Meta-analysis found no significant differences between the intervention and control groups for any of the four outcomes: maternal or neonatal colonization or infection. The preferred method for chlorhexidine administration was vaginal irrigation.
Meta-analysis did not demonstrate improved maternal or neonatal outcomes with intrapartum vaginal chlorhexidine cleansing, however this may be due to the limitations of the available studies. A larger, multicentre randomised controlled trial, powered to accurately evaluate the effect of intrapartum vaginal chlorhexidine cleansing on neonatal outcomes may still be informative; the technique of douching may be the most promising.
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