Equity for Suction Tamponade Access to treat postpartum haemorrhage: The ESTA project.

Context Excessive bleeding after childbirth (postpartum haemorrhage, PPH) causes many deaths worldwide, most of which are avoidable with proper treatment. PPH usually occurs because the womb (uterus) does not contract enough after birth to compress the bleeding uterine vessels. When medical methods fail, standard care has been to insert a balloon into the uterus and inflate it with saline. Although this inhibits uterine contractions, it obstructs the bleeding vessels. A recent development has been to replace this balloon with a suction catheter which stimulates a uterine contraction thus stopping the bleeding. There is increasing evidence that this is more effective and, in the USA, the FDA-approved Jada suction device has quickly become the mainstay of treatment for persistent PPH with 90% success rates. The challenge the project addresses The current cost of the disposable Jada device (available only in the USA at US$ 1200 each) puts it far out of reach of the low-income settings where most PPH deaths occur, leading to global inequity in care. We propose an affordable device with several functional advantages over the Jada device to expand access to this life-saving technology. Our proposed solution The ideal suction tube device should be easy to insert, minimally intrusive for the mother, and slimline so that it can be inserted during or after elective caesarean birth. We have shown in several clinical studies that this can be achieved with a simple ‘Levin’ tube, originally developed for stomach drainage. Although inexpensive, this approach may have advantages over the Jada device, which has a bulky, racquet-shaped suction section (limiting insertion after caesarean birth) and a balloon collar requiring inflation (Figure 1). We propose to use our longstanding experience with the Levin tube to develop a low-cost suction device specifically designed and registered for uterine tamponade. We will also develop a manual suction source to provide suction without need for electricity. For this application, we will contract Sinapi Biomedical (with South African and UK branches) to develop and produce a prototype device for initial proof of concept clinical testing. Sinapi currently manufactures the Ellavi balloon tamponade device and distributes medical devices in the UK and globally. The central tube of the Ellavi has been safely inserted into many thousands of uteri in clinical practice, and, with the balloon removed, provides the starting point for a suction tamponade tube (Figure 1). Aims and objectives Our aim is to improve access to suction tube uterine tamponade for the treatment of PPH globally. Our specific objectives of the current application are: To use existing manufacturing technology to develop and manufacture an inexpensive, effective suction tamponade device To demonstrate technical equivalence to previous methods through simulation testing To conduct ‘proof of concept’ clinical testing, replicating our prior published work with the improvised suction tube. To establish a clear pathway to future registration and distribution, including a funding plan. Potential benefits and applications An affordable device will address current global inequity in access to this life-saving technology Novel features of the device will make it uniquely suitable for widespread application including during or after elective caesarean birth, by midwives or ambulance personnel and in rural settings without access to electricity. Current clinical evidence suggests that a simple tube-like device may be simpler and less painful to insert than currently registered more complex technology.