Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study.

OBJECTIVES: Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. DESIGN: A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. SETTING: Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. PARTICIPANTS: Obstetric staff (n=451) working within participating facilities. INTERVENTION: PPH management training courses were conducted with obstetric staff. PRIMARY AND SECONDARY OUTCOME MEASURES: Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. RESULTS: All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. CONCLUSIONS: The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. TRIAL REGISTRATION NUMBERS: NCT04502173; NCT05340777.

Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in the ACROBAT pilot trial for severe postpartum haemorrhage.

OBJECTIVE: The ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent. This study aimed to build an understanding of how the deferred consent procedures worked in practice, to inform plans for a full-scale trial. SETTING: Qualitative interview study within a cluster-randomised pilot trial, involving four London maternity services. PARTICIPANTS: Individual interviews were conducted postnatally with 10 women who had received blood transfusion for severe postpartum haemorrhage and had consented to the trial. We also interviewed four 'recruiters'-two research midwives and two clinical trials practitioners who conducted trial recruitment. RESULTS: Consent procedures in the ACROBAT pilot trial were generally acceptable and the intervention was viewed as low risk, but most women did not remember much about the consent conversation. As per trial protocol, recruiters sought to consent women before hospital discharge, but this time pressure had to be balanced against the need to ensure women were not approached when distressed or very unwell. Extra efforts had to be made to communicate trial information to women due to the exhaustion of their recovery and competing demands for their attention. Participant information was further complicated by explanations about the cluster design and change in transfusion process, even though the consent sought was for access to medical data. CONCLUSION: Our findings indicate that deferred consent procedures raise similar concerns as taking consent when emergency obstetric research is occurring-that is, the risk that participants may conflate research with clinical care, and that their ability to process trial information may be impacted by the stressful nature of recovery and newborn care. A future trial may support more meaningful informed consent by extending the window of consent discussion and ensuring trial information is minimal and easy to understand. TRIAL REGISTRATION NUMBER: ISRCTN12146519.

Patient blood management and blood conservation - Complimentary concepts and solutions for blood establishments and clinical services in South Africa and beyond.

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.

Coronavirus disease 2019 in pregnancy: early lessons.

The worldwide incidence of coronavirus disease 2019 (COVID-19) infection is rapidly increasing, but there exists limited information on coronavirus disease 2019 in pregnancy. Here, we present our experience with 7 confirmed cases of coronavirus disease 2019 in pregnancy presenting to a single large New York City tertiary care hospital. Of the 7 patients, 5 presented with symptoms of coronavirus disease 2019, including cough, myalgias, fevers, chest pain, and headache. Of the 7 patients, 4 were admitted to the hospital, including 2 who required supportive care with intravenous hydration. Of note, the other 2 admitted patients who were asymptomatic on admission to the hospital, presenting instead for obstetrically indicated labor inductions, became symptomatic after delivery, each requiring intensive care unit admission.

Dangerous shortage of blood banks as an indirect effect of SARS-CoV-2: An obstetrics perspective.

OBJECTIVE: To describe the impact of the SARS-CoV-2 pandemic on the frequency of blood donation (BD) in a Latin American hospital and how the social isolation policy implemented during the pandemic jeopardizes the quality of postpartum hemorrhage (PPH) care due to shortages at blood banks (BB). METHODS: A retrospective, descriptive study was conducted, lasting for 31 months, including the start of the pandemic. Frequency of BD and the use of obstetric emergency services was observed. RESULTS: A direct relationship was observed between the pandemic and a decrease in BD. Although emergency obstetric visits decreased, the frequency of deliveries and cases of PPH remained unchanged. After applying strategies to promote voluntary BD, a very slight increase was observed in the frequency of BD, with a negative indicator persisting between donation and blood demand. CONCLUSION: The SARS-CoV-2 pandemic has led to shortages at BBs. In this context, typical measures to encourage an altruistic attitude toward BD have not had a significant impact. As causes of PPH continue, quality of care may be affected by the current situation at BBs. Governments and institutions must implement new strategies to motivate BD.