What did the project achieve?
“This study has improved understanding of the biological mechanism for how a potential new combination treatment for preventing preterm labour might work – and established it is safe for pregnant women,” says Professor Mark Johnson of Imperial College London. “Based on these promising results, we are now hoping to set up a larger clinical trial to evaluate the potential benefits of the approach for women at high risk of preterm labour.”
Around 60,000 babies are born prematurely in the UK each year.1-2 Babies born too soon can face difficulties with breathing, feeding and fighting infection. Many of those born very early develop lifelong conditions such as cerebral palsy, blindness and learning difficulties.
Professor Johnson’s team has gathered evidence from previous laboratory studies suggesting that combining progesterone with a medicine called aminophylline could work better than either medicine alone at preventing preterm labour. They have now carried out further experiments in laboratory models to investigate how these medicines might act in the body.
“Our latest results suggest that the combination treatment works by dampening inflammation in the muscles in the womb,” says Professor Johnson.
The team also recruited 70 women at high risk of preterm labour to take part in a study to investigate the feasibility of carrying out a larger clinical trial to evaluate the potential benefits of the combination treatment.
“Our findings so far show that combining progesterone with aminophylline is safe for pregnant women at high risk of preterm labour and the treatment was well tolerated,” says Professor Johnson. “We are currently analysing blood and tissue samples collected from the women who took part – and hoping to set up a much larger clinical trial to evaluate whether the combination treatment is effective at preventing preterm birth.”
This research was completed on
Around 60,000 babies are born prematurely every year in the UK.1-5 Tragically, around 1,200 of these babies die4-6 Many others who survive a very early birth develop lifelong disabilities. Treatment with a hormone called progesterone can reduce a woman’s risk of giving birth early, but it doesn’t work for everyone. Professor Mark Johnson, of Imperial College London, is investigating whether combination treatment with progesterone and a medicine called aminophylline works better. His ultimate goal is to stop so many babies from being born too soon, save their lives and improve their health – both at birth and throughout their lives.
How are babies’ lives affected now?
“Premature birth is the biggest killer of babies in the UK,” says Professor Johnson.1, 6-8 “Worldwide, prematurity is the single largest cause of death in children under five.”9-10
All newborn babies are vulnerable, but those born very early are particularly so. They can face difficulties with breathing, feeding and fighting infections, and are at increased risk of developing lifelong conditions such as cerebral palsy, learning difficulties and hearing loss. They’re also more susceptible to some health problems during adulthood, such as high blood pressure and diabetes.
“Treatment with the hormone progesterone can reduce a woman’s chances of going into labour early if she’s at high risk of doing so,” says Professor Johnson. “However, many women still have their babies early even if they’re treated with progesterone, and this hormone doesn’t help women who are carrying twins.”11-12
How could this research help?
“We’re investigating whether combination treatment with progesterone and another medicine called aminophylline benefits women who are at high risk of going into labour too soon,” says Professor Johnson. “Evidence we’ve gathered in laboratory studies suggests combination treatment would work better than either medicine alone.”
“Like progesterone, aminophylline has already been used widely during pregnancy,” says Professor Johnson. “It’s commonly used to treat asthma in pregnant women and to help with breathing in very premature babies.”
Around 70 pregnant women at high risk of giving birth too soon are taking part in this trial. The researchers are studying whether combination treatment prolongs the women’s pregnancies – whether it delays or prevents premature birth. They’re also investigating how treatment works in the laboratory.
“If combination treatment seems successful, we plan to set up a much larger clinical trial in many more women,” says Professor Johnson. “Our ultimate goal is to stop babies from being born too soon, save their lives and protect them from disability.”
2. Office for National Statistics. Births in England and Wales, 2013. Table 1. http://www.ons.gov.uk/ons/rel/vsob1/birth-summary-tables--england-and-wales/2013/stb-births-in-england-and-wales-2013.html Website accessed 12 May 2015.
3. Births in Scottish Hospitals. Year ending 31st March 2013. Publication date – 26th August 2014. Table 1. http://www.isdscotland.org/Health-Topics/Maternity-and-Births/Publications/2014-08-26/2014-08-26-Births-Report.pdf Table 5 Website accessed 12 May 2015.
4. Northern Ireland Statistics and Research Agency. Births. Live births 1887-2014. http://www.nisra.gov.uk/demography/default.asp8.htm Website accessed 2 December 2015.
5. Office for National Statistics Gestation-specific Infant Mortality, 2012. Table 3 Live births, neonatal and infant mortality by birthweight and gestational age at birth, http://www.ons.gov.uk/ons/rel/child-health/gestation-specific-infant-mortality-in-england-and-wales/2012/stb-gestation-specific-infant-mortality--2012.html Website accessed 12 May 2015.
6. Office for National Statistics. Correction notice. Child mortality statistics 2013. Table 6. http://www.ons.gov.uk/ons/rel/vsob1/child-mortality-statistics--childhood--infant-and-perinatal/2013/rft-cms-2013.xls Website accessed 12 May 2015.
7. Northern Ireland Statistics and Research Agency. Registrar General Annual Report 2013. Section 4. Stillbirths and infant deaths. Table 4.5 Stillbirths and infant deaths, by sex and cause, 2010 to 2014. http://www.nisra.gov.uk/demography/default.asp99.htm Website accessed 2 December 2015.
8. National Records of Scotland. Vital Events Reference Tables 2013. Section 4: Stillbirths and infant deaths. Table 4.5: Infant deaths, by sex and cause, Scotland, 2003 to 2013. http://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/general-publications/vital-events-reference-tables/2013/section-4-stillbirths-and-infant-deaths Website accessed 12 May 2015.
9. World Health Organisation. Global Health Observatory (GHO) data. Causes of child mortality, 2013. http://www.who.int/gho/child_health/mortality/causes/en/ Website accessed 27 November 2015.
10. Liu L et al. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015; 385 (9966): 430-40. http://www.ncbi.nlm.nih.gov/pubmed/25280870 Website accessed 4 December 2015.
10. Romero R et al. Progesterone to prevent spontaneous preterm birth. Semin Fetal Neonatal Med 2014; 19: 15-26. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3934502/
11. Dodd JM et al. Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Published Online: 31 July 2013. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004947.pub3/abstract Website accessed 27 November 2015.
|Project Leader||Professor Mark R Johnson MBBS PhD MRCP MRCOG|
|Project Team||Dr Rachel M Tribe BSc PhDProfessor Phil R Bennett BSc PhD MD FRCOG|
|Project Location||Department of Obstetrics and Gynaecology, Chelsea and Westminster Hospital, Imperial College London|
|Project Location Other||Division of Women’s Health, St Thomas' Hospital, King’s College LondonInstitute for Reproductive and Developmental Biology, Hammersmith Hospital, Imperial College London|
|Project duration||2 years|
|Date awarded||20 July 2015|
|Project start date||1 March 2016|
|Project end date||1 November 2019|