An Overview of our previous work
CRADLE 1 Trial
CRADLE 1 incorporated field studies in Tanzania, Zambia and Zimbabwe, funded by a $100,000 Bill and Melinda Gates Foundation (BMGF) grant. Pregnant women were more commonly referred from community to health facility following the introduction of the device to local clinics than previously. It was also well accepted by users.
CRADLE 2 Trial (2015 – 2016)
Following the success of CRADLE 1 the Kings CRADLE group were successful in obtaining generous further funding from the Bill & Melinda Gates Grand Challenges Explorations ($1 Million). During this second phase of the project which took place in Mozambique, South Africa, Nigeria, India and Pakistan, the device was developed for improved accuracy in detection of low blood pressure and shock, and the traffic light early-warning-system was included.
CRADLE 3 Trial (2016-2018)
The primary aim was to determine whether widespread introduction of the Cradle VSA could reduce maternal mortality and major morbidity in 10 low-resource settings (Cap Hatien, Haiti; Freetown, Sierra Leone; Ndola, Zambia; Lusaka, Zambia; Harare, Zimbabwe; Gokak, India; Addis Ababa, Ethiopia; Mbale, Uganda; Zomba, Malawi). Maternal mortality and morbidity was reduced by up to 60% and 40% respectively in some sites.
VeSPA Trial (2018)
Vital Signs Alert Evaluating Shock Index in Pregnancy Anaemia
Up to 90% of pregnant women are anaemic in parts of rural India leading to increased risk of stillbirth, neonatal death and low birth weight. We carried out a study in 638 pregnant women attending antenatal care in Karnataka State in Southwest India, and found that the CRADLE VSA can be used to detect women who are likely to be suffering from anaemia, indicating that it can be used as a simple, cheap screening tool to highlight women needing iron supplementation.
An Overview of our ongoing work
CRADLE Scale-Up Sierra Leone (January 2020 to present)
The CRADLE Scale-Up project aims to increase access to vital signs monitoring for pregnant and postpartum women in Sierra Leone (which has the highest maternal mortality rate in the world), through national roll out of the CRADLE VSA in partnership with the Ministry of Health and Sanitation, to all government health facilities.
To date 636 health care providers have been trained and devices delivered to 74 health facilities across 2 of the 14 districts. By March 2021 the team hopes to have reached 6 of the 14 districts.
A proposal is currently being developed for Phase 2 which will involve training and device distribution to the remaining 8 districts, and developing interventions to address behavioural factors that impact the effectiveness of the CRADLE rollout.
CRADLE 4 Trial (2019 to present)
The CRADLE-4 trial is a randomised controlled trial which aims to establish the optimal timing of delivery in late preterm pre-eclampsia in a low and middle-income setting. The main objective is to evaluate whether pursuing a policy of planned early delivery in women with pre-eclampsia between 34+0 and 36+6 weeks of gestation can reduce adverse pregnancy outcomes, compared to routine (expectant) management. After 18 months of preparatory work including a 6 month feasibility and acceptability study, we are now open to recruitment at 5 sites across India and Zambia. Women who agree to participate in the study are randomly allocated to one of two groups – either planned delivery or routine care. Our research teams then collect outcome data for each woman and her baby up until primary hospital discharge. Recruitment to date stands at 77 participants, and we are shortly due to open two further sites in Zambia.
HAPPEE PROJECT (2018 to present)
Humanities and Arts in Preventing Pre-eclampsia complications through community Engagement and Education.
The HAPPEE Partnership Project is an interdisciplinary collaboration aiming to improve education around pre-eclampsia and hypertension in pregnancy. The project is divided into three main phases.
Phase 1 involved qualitative work in Zimbabwe and Haiti to understand the knowledge, experience and help-seeking patterns of women and the wider community in relation to maternal care and particularly hypertension in pregnancy. We interviewed pregnant women, new mothers, male and female decision makers, community and religious leaders, traditional birth attendants and traditional and faith healers and healthcare professionals. The aim was not only to scope levels of knowledge with respect to symptoms and danger signs in pregnancy but also to explore potential socio-cultural barriers to women accessing care.
Phase 2 of the project involved the development of culturally sensitive and context specific materials to address educational barriers. Film emerged as a potential vehicle for community engagement and education. (https://www.youtube.com/watch?v=RL2Lsk-0nSY)
During Phase 3 the resources that have been created will be piloted in Zimbabwe and Haiti, followed by a larger effectiveness trial.
CRADLE Refugee Project (April 2018 to present)
Uganda hosts 1.4 million refugees across 13 UN Refugee Agency (UNHCR) coordinated sites including Bidibidi, the world’s second largest refugee settlement which spans 230km2 and hosts 270 000 refugees, mainly from South Sudan.7 The health workforce is less than 10% of what is needed to deliver basic healthcare8 and relies heavily on non-medically trained community healthworkers. Since April 2018 we have delivered CRADLE VSA devices and training to over 1000 community and health facility workers across 3 refugee settlements (Bidibidi, Nakivale, Kyangwali) in Uganda.
Malaria is a leading cause of mortality and morbidity in Uganda, accounting for nearly a quarter of deaths. Low cost identification of severe Malaria by Community Health Workers is desirable to confirm diagnosis and enable prompt initiation of treatment. Our aim was to evaluate the CRADLE VSA to aid screening for Malaria by Community Health Workers. Patients with a raised shock index indicated by a yellow flashing light and a downward arrow on the CRADLE VSA were 11 times more likely to have severe Malaria than those with a normal shock index – the CRADLE VSA could represent a low cost easy-to-use to assist early detection of those with severe Malaria.
Up to a quarter of the Uganda population suffer from high blood pressure and the majority are unaware of its long term consequences. There is a need for activities to support prevention, early detection and early treatment of NCDs, which are currently estimated to account for 27% of total deaths in Uganda. Our aim was to carry out a survey of blood pressure lead by Community Health Workers equipped with CRADLE VSA devices. The prevalence of Hypertension in Bidibidi Refugee settlement is 19% and 4% have severe Hypertension. The CRADLE VSA is a useful tool for village and clinic screening.
During our work we noted challenges, including lack of access to solar power to charge the CRADLE VSA devices and an inefficient, unsafe paper-based referral and medical record system.
In answer to challenges related to the referral process we are currently developing i-CRADLE, a digital mobile and web platform with 3 key functions: 1) Referral and decision support: enables prompt referral and prevents loss of patient follow-up; 2) Education: on/offline access to vast library of guidelines/training videos; 3) Data collection: real-time collection/ collation of accurate health data directly from the frontline. (see i-CRADLE video: https://youtu.be/yjmCmr-jers). We are currently trying to obtain funding for solar power packs and to support a pilot of i-CRADLE in Bidibidi Refugee Settlement.
- UNHCR Uganda – Bidibidi Refugee Settlement Masterplan as of 16th May 2019. [Accessed at https://data2.unhcr.org/en/documents/details/74319 on 25th May 2020.]
- The Republic of Uganda Ministry of Health. Operational Guidelines on COVID-19 for Village Health Teams (VHTs). [Accessed at https://kiruhura.go.ug/sites/default/files/COVID19OperationalGuidelinesVHTs.pdf on 25th May 2020]