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.

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.

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.