Implementation of continuous-wave Doppler ultrasound to detect the high-risk foetus in the low-risk mother: lessons from South Africa.

INTRODUCTION: Detecting the risk of stillbirth during pregnancy remains a challenge. Continuous-wave Doppler ultrasound (CWDU) can be used to screen for placental insufficiency, which is a major cause of stillbirths in low-risk pregnant women. This paper describes the adaptation and implementation of screening with CWDU and shares critical lessons for further rollout. Screening of 7088 low-risk pregnant women with Umbiflow™ (a CWDU device) was conducted in 19 antenatal care clinics at nine study sites in South Africa. Each site comprised a catchment area with a regional referral hospital and primary healthcare antenatal clinics. Women with suspected placental insufficiency as detected by CWDU were referred for follow-up at the hospital. A 35-43% reduction in stillbirths was recorded. METHODS: The authors followed an iterative reflection process using the field and meeting notes to arrive at an interpretation of the important lessons for future implementation of new devices in resource-constrained settings. RESULTS: Key features of the implementation of CWDU screening in pregnancy combined with high-risk follow-up are described according to a six-stage change framework: create awareness; commit to implement; prepare to implement; implement; integrate into routine practice; and sustain practice. Differences and similarities in implementation between the different study sites are explored. Important lessons include stakeholder involvement and communication and identifying what would be needed to integrate screening with CWDU into routine antenatal care. A flexible implementation model with four components is proposed for the further rollout of CWDU screening. CONCLUSIONS: This study demonstrated that the integration of CWDU screening into routine antenatal care, combined with standard treatment protocols at a higher-level referral hospital, can be achieved with the necessary resources and available maternal and neonatal facilities. Lessons from this study could contribute to future scale-up efforts and help to inform decisions on improving antenatal care and pregnancy outcomes in low- and middle-income countries.

Accuracy of a smartphone application for blood pressure estimation in Bangladesh, South Africa, and Tanzania.

Undetected and unmonitored hypertension carries substantial mortality and morbidity, especially during pregnancy. We assessed the accuracy of OptiBPTM, a smartphone application for estimating blood pressure (BP), across diverse settings. The study was conducted in community settings: Gaibandha, Bangladesh and Ifakara, Tanzania for general populations, and Kalafong Provincial Tertiary Hospital, South Africa for pregnant populations. Based on guidance from the International Organization for Standardization (ISO) 81,060-2:2018 for non-invasive BP devices and global consensus statement, we compared BP measurements taken by two independent trained nurses on a standard auscultatory cuff to the BP measurements taken by a research version of OptiBPTM called CamBP. For ISO criterion 1, the mean error was 0.5 ± 5.8 mm Hg for the systolic blood pressure (SBP) and 0.1 ± 3.9 mmHg for the diastolic blood pressure (DBP) in South Africa; 0.8 ± 7.0 mmHg for the SBP and -0.4 ± 4.0 mmHg for the DBP in Tanzania; 3.3 ± 7.4 mmHg for the SBP and -0.4 ± 4.3 mmHg for the DBP in Bangladesh. For ISO criterion 2, the average standard deviation of the mean error per subject was 4.9 mmHg for the SBP and 3.4 mmHg for the DBP in South Africa; 6.3 mmHg for the SBP and 3.6 mmHg for the DBP in Tanzania; 6.4 mmHg for the SBP and 3.8 mmHg for the DBP in Bangladesh. OptiBPTM demonstrated accuracy against ISO standards in study populations, including pregnant populations, except in Bangladesh for SBP (criterion 2). Further research is needed to improve performance across different populations and integration within health systems.

Identifying the High-Risk Fetus in the Low-Risk Mother Using Fetal Doppler Screening.

Identifying the high-risk fetus in the low-risk pregnant mother (LRM) is a neglected area of research. Fetal growth restriction (FGR) is a major cause of stillbirths, especially in low- and middle-income countries (LMICs). FGR is very poorly detected particularly in healthy pregnant women classified as low risk. Umbiflow is an inexpensive continuous-wave Doppler ultrasound (CWDU) apparatus that is suitable for use by low-level health care providers for screening low-risk pregnant populations. It can easily detect umbilical artery blood flow in the cord, which correlates well with placental function, and poor placental function correlates well with FGR.Use of CWDU to screen an LMIC population of more than 7,000 LRMs has demonstrated a high prevalence of abnormal umbilical artery flow of 13%, and absent end-diastolic flow, which is associated with end-stage placental disease, was found in 1.2%. This is 10 times higher than previously reported in high-income countries. Screening with CWDU together with a standard protocol managing those pregnancies with abnormal placental blood flow resulted in a 43% reduction in stillbirths (risk ratio: 0.57; 95% confidence interval=0.29, 0.85) in this LRM population. Further, follow-up of infants who had abnormal umbilical artery blood flow showed that these infants had significantly less fat-free mass at ages 6 weeks, 10 weeks, 14 weeks, and 6 months, than those with normal umbilical artery blood flow (P<.015), confirming that CWDU was able to detect true FGR.Thus, screening with CWDU can detect the fetus at risk of stillbirth, and infants likely to have suboptimal growth and development postnatally. Screening with CWDU in LRMs opens the door to a step change in preventing stillbirths in LMICs.

Early Reflections on Mphatlalatsane, a Maternal and Neonatal Quality Improvement Initiative Implemented During COVID-19 in South Africa.

Despite global progress in reducing maternal and neonatal mortality and stillbirths, much work remains to be done to achieve the Sustainable Development Goals. Reports indicate that coronavirus disease (COVID-19) disrupts the provision and uptake of routine maternal and neonatal health care (MNH) services and negatively impacts cumulative pre-COVID-19 achievements. We describe a multipartnered MNH quality improvement (QI) initiative called Mphatlalatsane, which was implemented in South Africa before and during the COVID-19 pandemic. The initiative aimed to reduce the maternal mortality ratio, neonatal mortality rate, and stillbirth rate by 50% between 2018 and 2022. The multifaceted design comprises QI and other intervention activities across micro-, meso-, and macrolevels, and its area-based approach facilitates patients' access to MNH services. The initiative commenced 6 months pre-COVID-19, with subsequent adaptation necessitated by COVID-19. The initial focus on a plan-do-study-act QI model shifted toward meeting the immediate needs of health care workers (HCWs), the health system, and health care managers arising from COVID-19. Examples include providing emotional support to staff and streamlining supply chain management for infection control and personal protection materials. As these needs were addressed, Mphatlalatsane gradually refocused HCWs' and managers' attention to recognize the disruptions caused by COVID-19 to routine MNH services. This gradual reprioritization included the development of a risk matrix to help staff and managers identify specific risks to service provision and uptake and develop mitigating measures. Through this approach, Mphatlalatsane led to an optimization case using existing resources rather than requesting new resources to build an investment case, with a responsive design and implementation approach as the cornerstone of the initiative. Further, Mphatlalatsane demonstrates that agile and context-specific responses to crises such as the COVID-19 pandemic can mitigate such threats and maintain interventions to improve MNH services.

Preventing antenatal stillbirths: An innovative approach for primary health care.

BACKGROUND: In South Africa (SA), approximately 16 000 stillbirths occur annually. Most are classified as unexplained and occur in district hospitals. Many of these deaths may be caused by undetected foetal growth restriction. Continuous wave Doppler ultrasound of the umbilical artery (CWDU-UmA) is a simple method for assessing placental function. This screening method may detect the foetus at risk of dying and growth-restricted foetuses, allowing for appropriate management. METHODS: A cohort study was conducted across South Africa. Pregnant women attending primary health care clinics at 28-34 weeks gestation were screened using CWDU-UmA. Women not screened at those antenatal clinics served as control group 1. Control group 2 consisted of the subset of control group 1 with women detected with antenatal complications excluded. Women with foetuses identified with an abnormal CWDU-UmA test were referred and managed according to a standardised protocol. A comparison between the study and control groups was performed. RESULTS: The study group consisted of 6536 pregnancies, and there were 66 stillbirths (stillbirth rate [SBR]: 10.1/1000 births). In control group 1, there were 193 stillbirths in 10 832 women (SBR: 17.8/1000 births), and in control group 2, 152 stillbirths in 9811 women (SBR: 15.5/1000 births) (risk ratio: 0.57, 95% confidence intervals: 0.29-0.85 and 0.65, 0.36-0.94, respectively). CONCLUSION: Screening a low-risk pregnant population identified the low-risk mother with a high-risk foetus, and acting on the information as described was associated with a significant reduction (35% - 43%) in stillbirths. This demonstrates a step-change reduction in stillbirths and warrants screening in SA.

Coronavirus and Pregnancy: The Challenges of the 21st Century: A Review.

Despite many advances in medicine we are still faced with emerging pathogens. Pregnant women have been disproportionately affected by previous coronavirus outbreaks. The COVID-19 pandemic has not affected pregnant women as greatly as SARS-CoV and MERS, but has posed other challenges such as the need for quarantine and isolation, limited access to antenatal care, use of personal protective equipment (PPE), vaccine hesitancy and inequities in vaccine access and therapeutics between rich countries and the global south. This review will describe the impact of the significant coronaviruses on pregnancy, with special focus on the challenges being encountered by the SARS-CoV-2 global pandemic.

Implementing antenatal care recommendations, South Africa.

Despite progress in reduction in maternal deaths in South Africa, deaths due to complications of hypertension in pregnancy remain high at 26 deaths per 100 000 live births in 2016. The South African health ministry modified its existing four-visit antenatal care model to align with the World Health Organization's (WHO) 2016 recommendations for the number and content of antenatal care contacts. Implementation of the eight-contact antenatal care recommendations began in April 2017, after adaptation to the national context and nationwide trainings. In this article, we describe the stages of implementation and the monitoring of key indicators. We share lessons, particularly from the important early stages of nationwide scale-up and an analysis of the early results. We analysed samples of maternity case records in four catchment areas in the first year of the updated care model. The mean number of antenatal care contacts among five monthly samples of 200 women increased steadily from 4.76 (standard deviation, SD: 2.0) in March 2017 to 5.90 (SD: 2.3) in February 2018. The proportion of women with hypertension detected who received appropriate action (provision of medical treatment or referral) also increased from 83.3% (20/24) to 100.0% (35/35) over the same period. South Africa's experiences with implementation of the updated antenatal care package shows that commitment from all stakeholders is essential for success. Training and readiness are key to identifying and managing women with complications and developing an efficient antenatal care system accessible to all women.

En dépit des progrès observés dans la diminution des décès maternels en Afrique du Sud, les complications causées par l'hypertension durant la grossesse entraînent encore des pertes élevées, à savoir 26 sur 100 000 naissances en 2016. Le ministère de la Santé sud-africain a modifié son modèle de soins prénatals en quatre visites afin de s'aligner sur les recommandations 2016 de l'Organisation mondiale de la Santé (OMS) relatives au nombre et au type de contacts de soins prénatals. La mise en œuvre des recommandations de soins prénatals prévoyant au moins huit contacts a débuté en avril 2017, après adaptation au contexte du pays et formation à l'échelle nationale. Dans cet article, nous décrivons chaque étape de cette mise en œuvre et la surveillance des principaux indicateurs. Nous partageons les enseignements tirés, en particulier lors des premières étapes cruciales d'intensification au niveau national et d'analyse des résultats initiaux. Nous avons étudié des échantillons de dossiers de maternité dans quatre circonscriptions au cours de la première année d'instauration du nouveau modèle de soins. Le nombre moyen de contacts de soins prénatals sur cinq échantillons mensuels de 200 femmes a augmenté de manière stable, passant de 4,76 (écart type: 2,0) en mars 2017 à 5,90 (écart type: 2,3) en février 2018. Le pourcentage de femmes chez qui une hypertension a été détectée et qui ont bénéficié d'une prise en charge adéquate (traitement médical ou renvoi vers un spécialiste) a également augmenté, de 83,3% (20/24) à 100,0% (35/35) sur la même période. L'expérience de l'Afrique du Sud dans la mise en œuvre du nouveau modèle de soins prénatals montre qu'un engagement de la part de tous les intervenants est essentiel à la réussite de l'initiative. La formation et la préparation sont indispensables pour identifier et prendre en charge les femmes présentant des complications, mais aussi pour développer un système de soins prénatals efficace et accessible à toutes.

A pesar de los progresos realizados en cuanto a la reducción de las muertes maternas en Sudáfrica, las muertes por complicaciones debido a la hipertensión durante el embarazo siguen siendo elevadas, con 26 muertes por cada 100.000 nacidos vivos en 2016. El Ministerio de Salud de Sudáfrica modificó su actual modelo de atención prenatal de cuatro visitas para ajustarlo a las recomendaciones de la Organización Mundial de la Salud (OMS) para 2016 en cuanto al número y el contenido de los contactos de atención prenatal. La aplicación de las recomendaciones de atención prenatal de ocho visitas comenzó en abril de 2017, tras su adaptación al contexto nacional y la formación a nivel nacional. En el presente artículo se describen las etapas de aplicación y el seguimiento de los indicadores clave. Compartimos las lecciones, en particular, las importantes etapas iniciales de la ampliación a escala nacional y un análisis de los primeros resultados. Analizamos muestras de registros de casos de maternidad en cuatro zonas de captación en el primer año del modelo de atención actualizado. El número medio de contactos de atención prenatal entre cinco muestras mensuales de 200 mujeres aumentó de forma constante de 4,76 (desviación estándar, SD: 2,0) en marzo de 2017 a 5,90 (SD: 2,3) en febrero de 2018. La proporción de mujeres con hipertensión detectada que recibieron medidas adecuadas (suministro de tratamiento médico o remisión) también aumentó del 83,3% (20/24) al 100,0% (35/35) en el mismo período. Las experiencias en Sudáfrica en cuanto a la aplicación del conjunto de medidas actualizadas de atención prenatal demuestran que el compromiso de todos los interesados es esencial para el éxito. La formación y la preparación son fundamentales para identificar y tratar a las mujeres con complicaciones, así como para desarrollar un sistema eficiente de atención prenatal accesible a todas las mujeres.

Portable continuous wave Doppler ultrasound for primary healthcare in South Africa: can the EUnetHTA Core Model guide evaluation before technology adoption?

BACKGROUND: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce evidence gaps and interpret findings; and to assess a medical device by applying the EUnetHTA Core Model (CM) in South Africa and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care (PHC) setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound (DUS). METHODS: The scoping of the assessment was defined by involving policy makers in selecting the domains and corresponding questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. To substantiate evidence obtained from an initial literature review, different stakeholders were identified and consulted. The evidence generated fromall steps was used to populate the high-ranked assessment elements of the CM. RESULTS: The HTA on continuous-wave DUS incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on "health problem" and "safety" had a higher rank than the rest of the nine domains. Unexplained fetal mortality is the largest single contributor to perinatal deaths in South Africa. Pregnant women in PHC setting were examined using a continuous-wave DUS, after their routine antenatal visit. The healthcare professionals interviewed, indicated the benefit in the use of continuous-wave DUS in the PHC setting and the need for training. CONCLUSIONS: Collection and generation of evidence based on the HTA CM and the chosen decision criteria provided a generalized but structured guidance on the methodology. Several questions were not applicable for the technology and the context of its use and elimination of those that are inappropriate for the African context, resulted in a pragmatic solution. Engaging and consulting local stakeholders was imperative to understand the context, reduce evidence gaps, and address the uncertainties in the evidence, ultimately paving the way for technology adoption. Given the ongoing studies and the evolving evidence base, the potential of this technology should be reassessed.

Prevalence of abnormal umbilical arterial flow on Doppler ultrasound in low-risk and unselected pregnant women: a systematic review.

BACKGROUND: While Doppler ultrasound screening is beneficial for women with high-risk pregnancies, there is insufficient evidence on its benefits and harms in low- and unselected-risk pregnancies. This may be related to fewer events of abnormal Doppler flow, however the prevalence of absent or reversed end diastolic flow (AEDF or REDF) in such women is unknown. In this systematic review, we aimed to synthesise available data on the prevalence of AEDF or REDF. METHODS: We searched PubMed, Embase, CINAHL, CENTRAL and Global Index Medicus with no date, setting or language restrictions. All randomized or non-randomized studies reporting AEDF or REDF prevalence based on Doppler assessment of umbilical arterial flow > 20 weeks' gestation were eligible. Two authors assessed eligibility and extracted data on primary (AEDF and REDF) and secondary (fetal, perinatal, and neonatal mortality, caesarean section) outcomes, with results presented descriptively. RESULTS: A total of 42 studies (18,282 women) were included. Thirty-six studies reported zero AEDF or REDF cases. However, 55 AEDF or REDF cases were identified from just six studies (prevalence 0.08% to 2.13%). Four of these studies were in unselected-risk women and five were conducted in high-income countries. There was limited evidence from low- and middle-income countries. CONCLUSIONS: Evidence from largely observational studies in higher-income countries suggests that AEDF and REDF are rare among low- and unselected-risk pregnant women. There are insufficient data from lower-income countries and further research is required.