Pregnancy and childbirth have become much safer in many countries over the last few decades. According to the World Health Organisation (WHO), an estimated 289,000 women died during pregnancy and childbirth in 2013, a decline of 45% from 1990 levels, with some countries in Asia and Northern Africa more than halving their maternal mortality rate in the same period.
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However, there are still significant health risks for pregnant women – from preeclampsia, which affects about 8.5 million a year worldwide, to post-partum haemorrhage, which kills more new mothers than any other cause, an estimated 71,800 annually. No new pharmaceuticals have been approved by the FDA in this field since 2013, when morning sickness drug Bendectin, which was taken off the market over 30 years ago, won approval under the new name Diclegis.
That said, though, the pharmaceutical industry has been hard at work researching new possibilities for existing drugs – from steroids to vaccines and even compounds as simple as Omega-3 fatty acids – as well as developing new tests for existing conditions with the potential to hugely improve the standard of care for pregnant women.
Testing, testing
A new study published in the New England Journal of Medicine has found that a blood test developed by Roche can more confidently than ever before rule out the presence of preeclampsia. The condition is currently one of the biggest health threats to pregnant women and their babies, affecting 8.5 million women a year and accounting for 15% of preterm deliveries and 42% of maternal deaths globally.
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"This disease is complex and there has been a need to find a better way to support physicians in the diagnosis and management of these patients," says Paul Skingley, director of centralised solutions at Roche Diagnostics UK and Ireland.
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By GlobalDataEnter the company’s Elecsys blood test, which can not only predict with 99.3% confidence which women will not develop preeclampsia in the next week (a milestone achievement as there are currently no other tests that can be used to confidently rule out the presence of the condition), it can also predict which patients will develop preeclampsia in the next four weeks almost twice as accurately as current methods, which only offer 33.7% confidence.
"This is a big improvement, compared to the current standard of care, bringing significant benefits to patients and healthcare systems," Skingley notes.
Meanwhile, a new study led by King’s College London has found that offering a standard biomarker test earlier in the pregnancy could potentially help doctors to better identify women at risk of giving birth prematurely, enabling health services to focus treatments on women at highest risk. However, the authors have cautioned that these findings should not be used as the basis of deciding whether to use an early test as well as, or instead of, a later test.
Lead author Andrew Shennan, a professor of obstetrics at King’s College London and consultant obstetrician at Guy’s and St Thomas’ NHS Foundation Trust, said: "We hope to carry out further trials to establish whether biomarker testing at an earlier stage of pregnancy could help us to intervene where necessary before cervical shortening is normally detected, and thus improve the prospects of giving birth safely for more women."
Existing drugs, new possibilities
New research on common compounds has uncovered information that could significantly impact the obstetrics field. For example, researchers at the University of Granada and King’s College London have found that consuming Omega-3 during pregnancy could help reduce or prevent the risk of new-borns suffering from anaemia.
Specifically, the study proved for the first time that taking docosahexaenoic acid (DHA), an Omega-3 essential polyunsaturated fatty acid, enhances foetal iron metabolism, on top of helping in early brain development. "This DHA supplement is postulated as a nutritional strategy that not only helps in the cognitive and visual development of the baby, but also could help in preventing the risk of suffering anaemia. In this regard, this maternal supplementation could prevent anaemia-related perinatal complications such as low birth weight and late cognitive development," the lead authors explained.
Omega-3 isn’t the only common compound that could potentially have new uses. A study by the National Institutes of Health research network recently found that prenatal steroid therapy reduces the chance of respiratory complications among late preterm infants born at 34-36 weeks.
Previously, it was believed that these infants could thrive without their mothers having received steroid treatments, although steroids are already a standard treatment for women likely to deliver before 34 weeks of pregnancy because they are known to reduce respiratory and other complications, as well as death, among infants born early preterm.
"Eight percent of all deliveries occur in the late preterm period," said study author Uma Reddy, MD, MPH, of the pregnancy and perinatology research branch at the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. "Our results indicate that prenatal steroid therapy for women delivering late preterm could greatly reduce the rate of serious respiratory complications in this group of infants."
Vaccination innovations
Various new vaccination guidelines have been introduced over recent years for pregnant women. The Tdap vaccine for pertussis, also known as whooping cough, is now recommended during pregnancy in countries including the US and the UK and mandated for all pregnant women in Brazil.
In 2013, 109 pertussis-related deaths were reported in Brazil, a number seven-fold higher than the average number of deaths reported annually in the period from 2001 to 2010, and more than 80% of the deaths occurred in infants younger than three months of age.
A new vaccine for group B streptococcal (strep) bacteria in pregnant women is also one step closer to the healthcare setting after preliminary findings from a phase II study found a vaccine covering three strains of group B strep to be effective with no major safety concerns. Although more studies are necessary before FDA approval can be sought, a vaccine would significantly reduce the need for antibiotics in pregnant women during labour and in infants who contract a group B strep infection. While the bacteria are usually pretty harmless for adults, new-borns can develop severe infections as a result of coming into contact with it, including blood infections, pneumonia and meningitis.
Looking further to the future, scientists are racing to develop a vaccine for the Zika virus, which has spread to more than 20 countries in South and Central America, could potentially infect four million people by the end of the year and has been provisionally linked to birth defects. The challenge will lie in the need to test the drug on pregnant women, a group of people not normally involved in experimental trials, although Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, has said he is confident that pregnant women could be properly protected as early as 2017.
