Commentary: The proposed legislation on termination of pregnancy does not protect women or children in Malawi and is not fit for the intended purpose: Christian Medical and Dental Fellowshipi position

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Implementation of a novel ultrasound training programme for midwives in Malawi:A mixed methods evaluation using the RE-AIM framework

IntroductionDespite recommendation that all women receive an ultrasound in pregnancy prior to 24 weeks', this remains unavailable to many women in low-income countries where trained practitioners are scarce. Although many programmes have demonstrated efficacy, few have achieved longterm sustainability, with a lack of information about how best to implement such programmes. This mixed-methods study aimed to evaluate the implementation of a novel education package to teach ultrasound-naive midwives in Malawi basic obstetric ultrasound, assessing its impact in the context of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.MethodsThe study ran across six sites in Malawi between October 2020 and June 2021, encompassing three phases; pre-implementation, implementation and post-implementation. Twenty nine midwives underwent a bespoke education package with matched pre and post course surveys assessed their knowledge, attitudes and confidence and "hands on" assessments evaluating practical skills. Training evaluation forms and in-depth interviews explored their satisfaction with the package, with repeat assessment and remote image review evaluating maintenance of skills.Results28/29 midwives completed the training, with significant increases in knowledge, confidence and practical skills. Adherence to the education package varied, however many changes to the proposed methodology were adaptive and appeared to facilitate the efficacy of the programme. Unfortunately, despite reporting approval regarding the training itself, satisfaction regarding supervision and follow up was mixed, reflecting the difficulties encountered with providing ongoing in-person and remote support.ConclusionThis programme was successful in improving trainees' knowledge, confidence and skill in performing basic obstetric ultrasound, largely on account of an adaptive approach to implementation. The maintenance of ongoing support was challenging, reflected by trainee dissatisfaction. By evaluating the success of this education package based on its implementation and not just its efficacy, we have generated new insights into the barriers to sustainable upscale, specifically those surrounding maintenance

Midwife‐Led Ultrasound Scanning to Date Pregnancy in Malawi: Development of a Novel Training Program

The use of ultrasound to determine gestational age is fundamental to the optimum management of pregnancy and is recommended for all women by the World Health Organization. However, this modality remains unavailable to many women in low-income countries where trained practitioners are scarce. Although previous initiatives have demonstrated efficacy in training midwives and technicians to perform antenatal ultrasound, these programs have often been too long and too complex to be realistic within the specific constraints of this context, highlighting the need for a novel and pragmatic approach. We describe the development and piloting of a bespoke course to teach midwives 3 fundamental components of early antenatal ultrasound scanning: (1) to identify the number of fetuses, (2) to confirm fetal viability, and (3) to determine gestational age. Having established that 5 days is insufficient, we propose that the minimum duration required to train ultrasound-naive midwives to competency is 10 days. Our completed program therefore consists of one and one-half days of didactic teaching, followed by 8 and one-half days of supervised hands-on practical training in which trainees are assessed on their skills. This package has subsequently been successfully implemented across 6 sites in Malawi, where 28 midwives have achieved competency. By describing the processes involved in our cross-continental collaboration, we explain how unexpected challenges helped shape and improve our program, demonstrating the value of preimplementation piloting and a pragmatic and adaptive approach

Training in Ultrasound to Determine Gestational Age (TUDA): Evaluation of a Novel Education Package to Teach Ultrasound-Naive Midwives Basic Obstetric Ultrasound in Malawi

IntroductionAlthough ultrasound to determine gestational age is fundamental to the optimum management of pregnancy and is recommended for all women by the World Health Organisation, it remains unavailable to many women in low-income countries where trained practitioners are scarce. This study aimed to evaluate a novel, context-specific education package to teach midwives basic obstetric ultrasound, including the determination of gestational age by measurement of fetal femur length.MethodsThe study was conducted across six sites in Malawi in January 2021. Following a virtual “training of the trainers”, local teams delivered a 10-day programme encompassing both didactic and “hands on” components. Matched pre and post course tests assessed participants' knowledge of key concepts, with Objective Structured Clinical Examinations used to evaluate practical skills. To achieve a pass, trainees were required to establish the gestational age to within ±7 days of an experienced practitioner and achieve an overall score of &amp;gt;65% on five consecutive occasions. A matched pre and post course survey explored participants' attitudes and confidence in performing ultrasound examinations.ResultsOf the 29 midwives who participated, 28 finished the programme and met the criteria specified to pass. 22 midwives completed the matched knowledge tests, with the mean (SD) score increasing from 10.2 (3.3) to 18 (2.5) after training (P &amp;lt;0.0001). Mean difference 7.9, 95% CI 6.5–9.2. Midwives passed 87% of the Observed Structured Clinical Examinations, establishing the gestational age to within ±7 days of an experienced practitioner in 89% of assessments. Beliefs regarding the importance of antenatal ultrasound increased post course (p = 0.02), as did confidence in performing ultrasound examinations (p &amp;lt;0.0001).ConclusionThis study demonstrates not only that ultrasound-naive practitioners can be taught to perform basic obstetric ultrasound dating scans, confidently and competently, after 10 days of training, but also that local teams can be orientated to successfully deliver the programme virtually. Previous ultrasound training initiatives, while often more comprehensive in their syllabus, have been of considerably longer duration and this is likely to be a barrier to upscaling opportunities. We propose that this focused training increases the potential for widescale and sustainable implementation.</jats:sec

Implementation of a novel ultrasound training programme for midwives in Malawi: A mixed methods evaluation using the RE-AIM framework

INTRODUCTION: Despite recommendation that all women receive an ultrasound in pregnancy prior to 24 weeks', this remains unavailable to many women in low-income countries where trained practitioners are scarce. Although many programmes have demonstrated efficacy, few have achieved longterm sustainability, with a lack of information about how best to implement such programmes. This mixed-methods study aimed to evaluate the implementation of a novel education package to teach ultrasound-naive midwives in Malawi basic obstetric ultrasound, assessing its impact in the context of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. METHODS: The study ran across six sites in Malawi between October 2020 and June 2021, encompassing three phases; pre-implementation, implementation and post-implementation. Twenty nine midwives underwent a bespoke education package with matched pre and post course surveys assessed their knowledge, attitudes and confidence and "hands on" assessments evaluating practical skills. Training evaluation forms and in-depth interviews explored their satisfaction with the package, with repeat assessment and remote image review evaluating maintenance of skills. RESULTS: 28/29 midwives completed the training, with significant increases in knowledge, confidence and practical skills. Adherence to the education package varied, however many changes to the proposed methodology were adaptive and appeared to facilitate the efficacy of the programme. Unfortunately, despite reporting approval regarding the training itself, satisfaction regarding supervision and follow up was mixed, reflecting the difficulties encountered with providing ongoing in-person and remote support. CONCLUSION: This programme was successful in improving trainees' knowledge, confidence and skill in performing basic obstetric ultrasound, largely on account of an adaptive approach to implementation. The maintenance of ongoing support was challenging, reflected by trainee dissatisfaction. By evaluating the success of this education package based on its implementation and not just its efficacy, we have generated new insights into the barriers to sustainable upscale, specifically those surrounding maintenance

Informing prevention of stillbirth and preterm birth in Malawi:development of a minimum dataset for health facilities participating in the DIPLOMATIC collaboration

OBJECTIVE: The global research group, DIPLOMATIC (Using eviDence, Implementation science, and a clinical trial PLatform to Optimise MATernal and newborn health in low Income Countries), aims to reduce stillbirths and preterm births and optimise outcomes for babies born preterm. Minimum datasets for routine data collection in healthcare facilities participating in DIPLOMATIC (initially in Malawi) were designed to assist understanding of baseline maternal and neonatal care processes and outcomes, and facilitate evaluation of improvement interventions and pragmatic clinical trials. DESIGN: Published and grey literature was reviewed alongside extensive in-country consultation to define relevant clinical best practice guidance, and the existing local data and reporting infrastructure, to identify requirements for the minimum datasets. Data elements were subjected to iterative rounds of consultation with topic experts in Malawi and Scotland, the relevant Malawian professional bodies and the Ministry of Health in Malawi to ensure relevance, validity and feasibility. SETTING: Antenatal, maternity and specialist neonatal care in Malawi. RESULTS: The resulting three minimum datasets cover the maternal and neonatal healthcare journey for antenatal, maternity and specialist neonatal care, with provision for effective linkage of records for mother/baby pairs. They can facilitate consistent, precise recording of relevant outcomes (stillbirths, preterm births, neonatal deaths), risk factors and key care processes. CONCLUSIONS: Poor quality routine data on care processes and outcomes constrain healthcare system improvement. The datasets developed for implementation in DIPLOMATIC partner facilities reflect, and hence support delivery of, internationally agreed best practice for maternal and newborn care in low-income settings. Informed by extensive consultation, they are designed to integrate with existing local data infrastructure and reporting as well as meeting research data needs. This work provides a transferable example of strengthening data infrastructure to underpin a learning healthcare system approach in low-income settings.DIPLOMATIC is funded by the UK National Institute for Health Research

Interventions to reduce preterm birth and stillbirth, and improve outcomes for babies born preterm in low- and middle-income countries: A systematic review

BACKGROUND: Reducing preterm birth and stillbirth and improving outcomes for babies born too soon is essential to reduce under-5 mortality globally. In the context of a rapidly evolving evidence base and problems with extrapolating efficacy data from high- to low-income settings, an assessment of the evidence for maternal and newborn interventions specific to low- and middle-income countries (LMICs) is required. METHODS: A systematic review of the literature was done. We included all studies performed in LMICs since the Every Newborn Action Plan, between 2013 - 2018, which reported on interventions where the outcome assessed was reduction in preterm birth or stillbirth incidence and/or a reduction in preterm infant neonatal mortality. Evidence was categorised according to maternal or neonatal intervention groups and a narrative synthesis conducted. RESULTS: 179 studies (147 primary evidence studies and 32 systematic reviews) were identified in 82 LMICs. 81 studies reported on maternal interventions and 98 reported on neonatal interventions. Interventions in pregnant mothers which resulted in significant reductions in preterm birth and stillbirth were (i) multiple micronutrient supplementation and (ii) enhanced quality of antenatal care. Routine antenatal ultrasound in LMICs increased identification of fetal antenatal conditions but did not reduce stillbirth or preterm birth due to the absence of services to manage these diagnoses. Interventions in pre-term neonates which improved their survival included (i) feeding support including probiotics and (ii) thermal regulation. Improved provision of neonatal resuscitation did not improve pre-term mortality rates, highlighting the importance of post-resuscitation care. Community mobilisation, for example through community education packages, was found to be an effective way of delivering interventions. CONCLUSIONS: Evidence supports the implementation of several low-cost interventions with the potential to deliver reductions in preterm birth and stillbirth and improve outcomes for preterm babies in LMICs. These, however, must be complemented by overall health systems strengthening to be effective. Quality improvement methodology and learning health systems approaches can provide important means of understanding and tackling implementation challenges within local contexts. Further pragmatic efficacy trials of interventions in LMICs are essential, particularly for interventions not previously tested in these contexts

Vaginal vault haematoma following hysterectomy at a tertiary hospital

Thesis (MMed)--Stellenbosch University, 2016.Background Hysterectomy is the second most commonly performed surgical procedure among women of the reproductive age group, after caesarean section. Vault haematoma is a recognized complication of hysterectomy that may be associated with postoperative morbidity. Ultrasound examination of the vault is useful in the diagnosis of post hysterectomy vault haematoma as a cause for febrile morbidity. This study was conducted to determine the incidence and clinical significance of post hysterectomy vault hematomas in a South African Academic setting. Methods This was a prospective descriptive observational study. Women aged 18 and above, scheduled for elective hysterectomy for benign indications were enrolled in the study after providing written informed consent. Transvaginal ultrasound scan was done at 48-72 hours post-operative and clinical notes were reviewed 3 months postoperatively. Results Fifty patients were included in the study. Incidence of vault haematoma in this cohort was 30% (95% CI 18-44%). The majority of vault haematomas was 2-5cm in largest diameter (67%) followed by those that were more than 5cm (27%) and those less than 2cm (6%). There was no statistically significant difference in the incidence of vault haematoma between the different routes of hysterectomy (Fisher’s exact 0.124) There was no association between the presence of a vault haematoma and postoperative morbidity (fever, haemoglobin level, prolonged hospital stay, complications at follow up). None of the patients with vault haematoma was symptomatic up to the time of discharge from the hospital. One patient with a vault haematoma more than 5cm was readmitted on Day 15 postoperative with a foul smelling vaginal discharge that was treated successfully with oral antibiotics. Conclusions Vault haematoma is a common finding following elective hysterectomy for benign gynaecological indications. Patients with vault haematomas are mostly asymptomatic. There is no association between the presence of a vault haematoma and postoperative morbidity.Agtergrond Histerektomie is die tweede mees algemeenste chirurgiese prosedure wat uitgevoer word op vroue in die reproduktiewe ouderdomsgroep, na keisersnit. Koepelhematoom is ‘n erkende komplikasie van histerektomie wat geassosieer word met post-operatiewe morbiditeit. Ultraklank ondersoek van die koepel is waardevol in die diagnose van post-histerektomie koepelhematoom as ‘n oorsaak van koors. Hierdie studie is gedoen om die voorkoms en kliniese belang van post histerektomie koepelhematome in ‘n Suid-Afrikaanse akademiese hospitaal te bepaal. Metodes Dit is ‘n prospektiewe, beskrywende studie. Vroue, 18 jaar en ouer, wat bespreek was vir elektiewe histerektomie vir benigne indikasies, het deelgeneem aan die studie nadat skriftelike toestemming verleen is. Transvaginale ultraklank ondersoek is gedoen 48-72 ure postoperatief en kliniese notas tot 3 maande postoperatief is bestudeer. Resultate Vyftig pasiënte is bestudeer. Voorkoms van koepelhematoom in hierdie kohort was 30% (95% VI 18-44%). Die meerderheid van koepel hematome se grootste omtrek was 2-4cm (67%) gevolg deur sommige meer as 5cm (27%) en ‘n paar minder as 2cm (6%). Daar was geen statistiese verskil in die voorkoms van koepel hematoom tussen die verskillende histerektomie opsies nie (Fisher eksakte toets 0.124). Daar was geen assosiasie tussen die teenwoordigheid van koepel hematoom en post-operatiewe morbiditeit (koors, hemoglobienvlak, verlengde hospitaal verblyf, komplikasies by opvolg). Geen van die pasiënte met koepel hematoom was simptomaties tot en met ontslag van die hospitaal nie. Een pasiënt met ‘n koepel hematoom van meer as 5cm is heropgeneem op dag 15 postoperatief met ‘n slegruikende afskeiding wat suksesvol behandel is met orale antibiotika. Stellenbosch University https://scholar.sun.ac.za Page 9 of 35 Gevolgtrekkings Koepel hematoom kom algemeen voor na elektiewe histerektomie vir benigne ginekologiese indikasies. Pasiënte met koepel hematome is meestal asimptomaties. Daar is geen assosiasie tussen die voorkoms van koepel hematoom en post-operatiewe morbiditeit nie

Interventions to reduce preterm birth and stillbirth, and improve outcomes for babies born preterm in low- and middle-income countries: A systematic review

BACKGROUND: Reducing preterm birth and stillbirth and improving outcomes for babies born too soon is essential to reduce under-5 mortality globally. In the context of a rapidly evolving evidence base and problems with extrapolating efficacy data from high- to low-income settings, an assessment of the evidence for maternal and newborn interventions specific to low- and middle-income countries (LMICs) is required. METHODS: A systematic review of the literature was done. We included all studies performed in LMICs since the Every Newborn Action Plan, between 2013 - 2018, which reported on interventions where the outcome assessed was reduction in preterm birth or stillbirth incidence and/or a reduction in preterm infant neonatal mortality. Evidence was categorised according to maternal or neonatal intervention groups and a narrative synthesis conducted. RESULTS: 179 studies (147 primary evidence studies and 32 systematic reviews) were identified in 82 LMICs. 81 studies reported on maternal interventions and 98 reported on neonatal interventions. Interventions in pregnant mothers which resulted in significant reductions in preterm birth and stillbirth were (i) multiple micronutrient supplementation and (ii) enhanced quality of antenatal care. Routine antenatal ultrasound in LMICs increased identification of fetal antenatal conditions but did not reduce stillbirth or preterm birth due to the absence of services to manage these diagnoses. Interventions in pre-term neonates which improved their survival included (i) feeding support including probiotics and (ii) thermal regulation. Improved provision of neonatal resuscitation did not improve pre-term mortality rates, highlighting the importance of post-resuscitation care. Community mobilisation, for example through community education packages, was found to be an effective way of delivering interventions. CONCLUSIONS: Evidence supports the implementation of several low-cost interventions with the potential to deliver reductions in preterm birth and stillbirth and improve outcomes for preterm babies in LMICs. These, however, must be complemented by overall health systems strengthening to be effective. Quality improvement methodology and learning health systems approaches can provide important means of understanding and tackling implementation challenges within local contexts. Further pragmatic efficacy trials of interventions in LMICs are essential, particularly for interventions not previously tested in these contexts

DIPLOMATIC study documents

This archive comprises study documents including work packages 1 to 8, some of the materials include the following: - study protocol (an over-arching very detailed description of the experiment); - consent forms; - educational materials relating to ultrasound scanning and so on. ## Access ## Requests for a copy of the data are welcome. The data are held in the DataVault, which is directly accessible only to University of Edinburgh nominated users. To request a copy, please contact Lorraine Adamson.DIPLOMATIC is a clinical trial, a multidisciplinary international collaboration investigating interventions in pre-term birth and still-term birth in low and middle income countries. (DIPLOMATIC: using eviDence, Implementation science, and a clinical trial PLatform to Optimise MATernal and newborn health in low Income Countries)