For women in developed countries, the likelihood of dying from blood loss in childbirth is very slim owing to the routine administration of oxytocin – an injected hormone that stimulates continued contractions to aid blood clotting where the placenta has detached.
It is a different story, however, in developing countries where conditions make it difficult to keep the drug at the consistent cold temperature required and where sterile syringes are not always available.
This is particularly problematic in countries where many babies are born in remote community locations. An estimated 100,000 women in developing countries die each year during childbirth from post-partum haemorrhage.
But these mortality rates might soon be dramatically reduced through the development of a new, more climatically stable form of the life-saving drug. Researchers from Monash University in Melbourne have recently signed a co-development agreement with global pharmaceutical company GlaxoSmithKline (GSK) that will bring an inhaled form of the drug a step closer to reality
The agreement will allow for the conduct of clinical trials, which, if successful, will lead to manufacture of the product at scale for use in developing countries.
Dr Michelle McIntosh, the project leader and a senior lecturer at the Monash Institute of Pharmaceutical Sciences (MIPS), says inhaled oxytocin is ideal for low-resource settings because it remains stable in the heat; it is cheap, portable and, as pre-clinical trials have shown, simple to administer; and it is effectively absorbed through the lungs. In a best-case scenario, an inhaler product could be in use by 2018, she says.
Dr McIntosh and her Monash team have been involved in the product's design and development since its beginning seven years ago. "Now we really feel we could achieve our aim to prevent post-partum haemorrhage in women, wherever they live," she says.
GSK's inhaled oxytocin project leader Susie Fowles says the collaboration combines the company's knowledge in respiratory medicine and dry powder technology with Monash University's technical expertise in pharmaceutical research.
The goal is to provide a product that is effective when used by minimally trained health workers in homes, communities and primary clinics, and that has the potential to save the lives of vulnerable mothers in resource-poor settings.
"Improving health care for women during childbirth is an important part of GSK's mission and aligns strategically with the objectives of the newly formed Maternal and Neonatal Health R&D Unit," she says. "The GSK team is extremely passionate about working with MIPS to develop an innovative life-saving medicine and distribute it to the women that need it so desperately."
A commercial partner has been in Dr McIntosh's sights since 2011 when Hillary Clinton, then US Secretary of State, presented the MIPS team with a Saving Lives at Birth award for the "innovation most likely to be transformational in maternal health".
"That was the day we realised 'this could be big' and we needed to find a way to make it work so that it could achieve its potential to save women's lives," Dr McIntosh says. "At Monash we bring the product concept, pre-clinical research and scientific development to the table but we don't bring manufacturing, commercialisation and distribution – that's why we needed to form a partnership."
In support of the new collaboration, Dr McIntosh and her team have received significant funding from donor organisations including the Planet Wheeler Foundation, Geneva-based McCall MacBain Foundation and Grand Challenges Canada. These funding partners support the core research program and enable the Monash team to investigate cultural, logistical and training issues in countries where they hope to introduce inhaled oxytocin.
This in-country strategic work being undertaken in India, Tanzania and Uganda, and slated for Papua New Guinea and Indonesia, will ensure the product can be successfully implemented following regulatory approval.
"We could make the best possible oxytocin product that is stable for years and works brilliantly but if we don't educate people to use it, it will sit on the shelf and gather dust," Dr McIntosh says. "We need to map out a clear implementation and access strategy to ensure the product gets into the hands of the women who need it, and they can use it effectively."
Furthering Dr Michelle McIntosh's research in this field is another partnership developed with two scientific equipment companies, and with major philanthropic funding from the Helen Macpherson Smith Trust. This will establish a new A$3.5 million translational research laboratory at MIPS to support the design and development of new drug products aimed at improving global health and access to medicines. New treatments for tuberculosis and pneumonia that are suitable for conditions in developing countries are in Dr McIntosh's sights. Fittingly, it was the Helen Macpherson Smith Trust that donated to Dr McIntosh her first A$50,000 to help establish the laboratory from which inhaled oxytocin has emerged.
Post-partum haemorrhage is defined as the loss of more than 500mL of blood during childbirth.
99.4% of all maternal deaths worldwide occur in developing countries.
Women in the developing world are 160 times more likely to die from pregnancy-related complications than those in developed countries.
Post-partum haemorrhage accounts for a third of all pregnancy-related deaths in Africa and Asia.