Condoms can significantly reduce maternal mortality. But not in the way you might think
Condoms improve heath and save lives. There’s no doubt about that. But they’re not usually found on the end of a catheter. The Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device is a low-cost kit consisting of a condom tied to a catheter (a thin, sterile tube) and inflated with clean water to stem severe bleeding following childbirth — also known as post-partum haemorrhage or PPH.
More than 30 per cent of all maternal deaths worldwide are attributable to PPH, accounting for approximately 130,000 deaths and 2.6 million disabled women every year. The vast majority of cases of PPH occur in low-and middle-income countries. While UBT devices have been used for emergency obstetrics in high-income countries since the 1980s, the manufactured medical “Bakri” balloons often used are single-use and can cost over US$400 each.
An affordable solution to PPH
In 2009 Dr Thomas Burke, Chief of the Division of Global Health and Human Rights at Massachusetts General Hospital (MGH), was approached by the government of South Sudan and a donor fund to develop a community-based package to address maternal, newborn and child emergencies. Given the high risks associated with PPH, Dr Burke and the team at MGH set about trying to develop a less expensive, viable alternative to the standard UBT device.
“This was an extremely harsh environment with very little infrastructure, and we needed to find a new solution,” said Dr Burke. “We looked around the world for inspiration and found examples of creative obstetrican-gynaecologists in Bangladesh and Uganda who were making their own uterine balloon tamponades with gloves or condoms in place of the Bakri balloons. This prompted us to trial different examples, and we developed the ESM-UBT package from there, including a kit costing less than US$5, along with a training programme, wall charts, checklists and facility manuals.”
After initial trials in South Sudan and Kenya, the uterine balloon tamponade was recognised by the International Federation of Obstetrics and Gynecology, and integrated into the WHO’s standard treatment procedures for PPH in 2012. However, there was still a limited amount of systematic data guiding implementation and understanding of UBT interventions in ultra-low resource settings.
Implementation in Sierra Leone
In late 2013 Elrha’s Humanitarian Innovation Fund awarded a two-year grant to kick-started the first systematic implementation and evaluation of the ESM-UBT package in Sierra Leone, a country that was torn apart by civil war from 1991 until 2002.
In emergency and post-emergency situations, there is often a lack of access to reproductive health services. Sierra Leone remains at the bottom of the UN Human Development Index (179 out of 188 in 2012) and the maternal mortality ratio (1,360 per 100,000 live births) is the highest in the world. Indeed, nine of the ten countries with the highest maternal mortality ratios in the world have been affected by current or recent conflict.
“We believe that these particular health workers represent those who would be on the frontlines during a humanitarian disaster in Sierra Leone and beyond”, said Dr Burke, but he acknowledges that they had to strike a balance between conducting rigorous research and being representative of a humanitarian emergency scenario: “Ultimately we had concerns about the efficacy of conducting a rigorous research study in a setting that lacks the infrastructure to allow for the collection of quality data.”
MGH staff ran an initial two-week “train the trainer” programme in December of 2013, with each of the trained health workers then expected to teach staff members in their own facilities how to use the ESM-UBT. Ministry of Health “UBT champions” carried out subsequent trainings and facility visits with support from the MGH team. In total, 542 health care workers across 105 health care facilities in the catchment area of Freetown were trained in how to implement ESM-UBT.
It was the relationship with key people at the Ministry of Health that proved vital for the project. “Our success in Sierra Leone was due in large part to Dr Kargbo, the Sierra Leone Director of Reproductive and Child Health,” said Dr Burke. “He would regularly drive out to facilities on his own to check in with them. He was a remarkable champion. We learned that solutions cannot be delivered from the outside. They can be supported from the outside, but they have to be driven internally.”
Ebola crisis
On top of the challenges already inherent in implementing the ESM-UBT package in Sierra Leone, the project was thrown into further difficulty with the outbreak of Ebola in May 2014. Initially, the programme remained resilient, but in early September problems started to arise — a three-day government shut-down for Ebola management training interrupted data collection, and shortly after the government informed the MGH team that all resources were being diverted to the Ebola response.
“The project was very significantly affected by the Ebola epidemic. We had to leave Sierra Leone. There was a lot of turmoil,” said Dr Burke. It was around this time that Moytrayee Guha joined the project. “I started after the Ebola crisis, when data collection and training had been heavily stalled,” said Ms Guha, “It was not a priority for the government at the time, but we did go back to do refresher trainings, and we’ve had a lot of continued support for the package.”
Project findings
Despite these challenges, the results from Sierra Leone are impressive. Over the first six months the ESM-UBT device was used 40 times in situations where women had failed to respond to non-surgical treatment for PPH, with many in the late stages of shock. Thirty-seven of these women survived — an overall rate of 93 per cent. Combined with data from further research in Kenya, Nepal and Senegal, the picture is even brighter. The results of a case series of 201 ESM-UBT device uses across all four countries showed an overall survival rate of 98% from uncontrolled PPH.
The ESM-UBT device has been used hundreds of times since those initial six months, and according to Dr Burke, the implementation in Sierra Leone was, and continues to be, a key contributor to the global movement to end PPH deaths: “We look around the world and we see ending PPH deaths as a march that we’re lucky enough to play an important role in, and it’s really with great thanks to the HIF.”
Dr Burke now has his sights on the bigger picture: “We’ve spent a lot of time thinking about how to scale up this intervention. We thought about open sourcing the kits, but research looking at improvised kits showed over and over again that the survival rate is much lower.” Instead, the team are working with a social enterprise in Kenya, talking to potential private-sector investors in India, and to the Inter-American Bank about implementation across several countries in Latin America.
“There have been big changes since we got the award”, said Burke. “We have been supporting 13 countries on implementation of the ESM-UBT package, leaning heavily on data from Sierra Leone. What’s even more exciting is to see thought leaders on board, quoting our research. We see many countries implementing this innovation, even without us, which is a wonderful marker of success.
