Following the development of the accurate, robust CRADLE VSA device we are yet to determine whether widespread implementation will have a worthwhile impact. To this end, we have obtained a £1.1 million Medical Research Council/Department of Biotechni India grant to evaluate implementation of the device at all healthcare levels in a stepped-wedge randomised controlled trial. This has commenced with preliminary pilot phase in November 2015 in Zimbabwe, Ethiopia and India. The main trial will commence in ten low-income settings including Uganda, Sierra Leone, Ethiopia and Haiti in March 2016.
Aim:
The primary aim is to determine whether implementation of the device with a simple education package across all healthcare providers at community and facility levels will reduce maternal mortality and major morbidity in low-income country populations. We hope that by training people how to recognise earlier those mothers that are becoming unwell in pregnancy, they will receive treatments earlier and rates of maternal death and these severe outcomes will reduce.
Outcomes:
The combined main outcomes of the trial are rates of maternal death, hysterectomy, stroke, eclampsia (fit from high blood pressure) and intensive care admission.
The traffic light is a visual trigger to alert health care professionals, and indeed, mothers themselves, when they need to act. The training package is simple but teaches health care professionals what the lights mean and how best to act depending on the infrastructure and resources available to them. You can view the training films and posters that are being developed for the trial on the resources page.
The CRADLE 3 primary investigators
(from left to right):
Hannah Nathan (King’s College London), Elodie Lawley (King’s College London), Lucy Chappell (King’s College London), James Ditai (Sanyu Africa Research Institute, Uganda), Sebastian Chinkoyo (Ndola Central Hospital, Zambia), Mrutyunjaya Bellad (KLE University, India), Shivaprasad Goudar (KLE University, India), Grace Greene (Haiti Hospital Appeal), Josaphat Byamugisha (Makerere University, Uganda), Andre Moll (Microlife), Matt Clarke (Welbodi, Sierra Leone), Andrew Shennan (King’s College London), Francis Gidiri (University of Zimbabwe, Zimbabwe), Adrian Brown (Maternity Worldwide), Annettee Nakimuli (Makerere University, Uganda), Ayesha Osman (University of CapeTown, South Africa), Grace Makonyola (Zomba, Malawi), Jane Sandall (King’s College London), Lomi Kumsa Yadeta (Addis Ababa, Ethiopia), Tafadzwa Muchengwa (Morgenster Mission Hospital, Zimbabwe), Paul Seed (King’s College London), Bellington Vwalika (University of Zambia, Zambia), Carwyn Hill (Haiti Hospital Appeal), Nicola Vousden (King’s College London).
