Motion made, and Question proposed, That this House do now adjourn.—(Claire Perry.)
I am delighted and honoured to have secured this debate on group B streptococcus, which is also known as group B strep or GBS. GBS is the most common cause of serious infection in newborn babies. In the UK, it is the most common cause of meningitis in babies in their first weeks of life. With prompt and aggressive treatment, most sick babies will recover from GBS infection, but even with the best medical care, about 10% of them will die, and some of the survivors will suffer lifelong problems, including 50% of those who recover from GBS meningitis.
The subject was last raised in the House 10 years ago by my right hon. Friend the Member for Witney (Mr Cameron), who is now Prime Minister. There has been some progress but, given his current position, it would be encouraging if we could see more. I shall quote his words at the end of my speech.
The rate of confirmed cases of group B strep infection in newborn babies increased by almost 50% between 1991 and 2010. The true rate of infection, which includes cases that are not confirmed through the identification of the bacteria, but in which GBS is strongly suspected by clinicians, is likely to be several times higher. The issue is therefore not only serious, but one that is becoming more serious.
We have known for a long time that the key risk factor for a newborn baby in developing GBS is the mother carrying GBS at delivery. The UK guidelines state that if GBS has been detected during the current pregnancy from a swab or culture from a pregnant woman, she should be offered intravenous antibiotics in labour to minimise the risk of GBS developing in her newborn baby.
The UK’s risk-based strategy to reduce GBS infection in newborn babies was introduced by the Royal College of Obstetricians and Gynaecologists in 2003, but there is no evidence that it has appreciably reduced the incidence of this devastating infection. In 2003, there were 229 reported cases of GBS infection in babies aged nought to six days; in 2011, there were 281 cases. On that evidence alone, I suggest to the Minister that the risk-based strategy has failed demonstrably and that we need to consider new alternatives.
One UK case study found that 21% of women carried GBS, and that 22% had risk factors for GBS infection developing in their newborn baby and would therefore be offered intravenous antibiotics in labour. However, only 29% of women with risk factors actually carried GBS. Using risk factors alone means that a high proportion of women not carrying GBS will be offered intrapartum antibiotics, while many actually carrying it will not.
Motion lapsed (Standing Order No. 9(3)).
Motion made, and Question proposed, That this House do now adjourn.—(Claire Perry.)
“The most striking finding that has implications for clinical practice and policy is the low sensitivity of risk factor based screening, compared with PCR or culture tests in predicting maternal and neonatal GBS colonisation—”
I warmly commend my hon. Friend on bringing the issue before the House. I have a constituent who lost a child as a result of it, so it is something that I take seriously. Is my hon. Friend pleased, as I am, to see that Public Health England is now adopting gold standard enriched culture testing in its eight regional laboratories? Does she welcome that as a small advance in this important area?
I welcome my hon. Friend’s intervention, and I will go on to talk about the gold standard culture medium.
The researchers continued that the sensitivity of such screening was
“below that which we considered to be a minimally acceptable sensitivity for our study—which calls into question the validity of the current UK policy. Moreover, consistent with previous evidence of practice variation, the risk factor-based screening policy was poorly adhered to, with one-third of women with indications for IAP not treated.”
Despite those authors and numerous others recommending routine screening as cost-effective in the UK, the UK national screening committee continues to recommend the risk-based approach.
Most countries that have national strategies against GBS infection offer routine antenatal testing for GBS. Those countries have seen the incidence of early onset disease fall dramatically, such as by more than 80% in the US and Spain. That compares favourably with the result of the risk-based approach in the UK under which, as I have said, the number of infections has increased. If we know that the risk-based strategy we are adopting is not working because infections are beginning to increase, yet countries such as Spain are seeing an 80% reduction, should we not consider the cost-effectiveness of moving to a system that we know will reduce the number of poorly babies in our intensive care units that have GBS-induced meningitis and other complications?
Studies show that testing for GBS in late pregnancy, as well as offering tests to women found to carry GBS or who have other recognised risk factors, is more cost-effective than the current risk-based strategy. A risk-based strategy is poor at predicting women who will be carrying GBS in labour, and therefore women for whom antibiotics in labour would potentially prevent devastating infections in their newborn babies.
Recently published research shows that although women want to be informed about GBS and offered testing for it during pregnancy, that is not happening. At less than £12, the tests are not that expensive, and the antibiotic recommended during labour if a woman is found to carry GBS in pregnancy is cheap and cost-effective. It is penicillin, which is shown to be exceptionally safe, as well as being a narrow-spectrum drug that is unlikely to cause greater resistance later.
Most NHS pathology services currently use culture media that are general purpose and identify GBS in only about 60% of carriers. At the request of the chief medical officer, Dame Sally Davies, the enriched culture medium test that my hon. Friend mentioned will be made available throughout England from 1 January 2014. That will identify about 90% of carriers, and it is the gold standard for that purpose, under Public Health England’s regional laboratory standard operating procedure. The results of the GBS test are about 85% predictive of carriage status for up to five weeks. It should be used to identify GBS carriage wherever there is an indication. These sensitive tests have not previously been widely available within the NHS when requested by the health professionals and pregnant women.
I have some key questions for the Minister. Will he use this debate as an opportunity to make a statement welcoming the gold standard enriched culture medium test for group B strep carriage, which is being made available from January 2014 and which can be used to assess carrier state if there is an indication? From this point on, how does the Minister plan to reduce the incidence of GBS infection in newborn babies when the current risk-based strategy, introduced in 2003, has been shown not to be effective? Is there a target rate for GBS infection in newborn babies? I have always derided targets, but in this case setting a target for the reduction of GBS infections may be a way to introduce routine testing.
Will the Minister confirm that the audit of practice suggested by the UK national screening committee to establish how well the new guidance is being implemented at a national level will study the actual practice taking place in maternity units, rather than simply being an audit of policies without any check on whether they are being applied in practice, because we know that these policies are not being put into practice in maternity units? What is the time scale for the feedback and advice to trusts about how they can further improve their adherence to the RCOG and National Institute for Health and Care Excellence guidelines on the prevention of neonatal GBS disease? What provision is being made for telling pregnant women about the risk of GBS infection in their babies? What provision is being made to educate relevant health professionals about the prevention of GBS in newborn babies and the forthcoming availability of the gold standard ECM test? Do midwives and practitioners in maternity units even know that this gold standard test is being introduced in 2014?
UK guidelines recommend that when GBS carriage is found by chance during a pregnancy, it should trigger the offer of antibiotic prophylaxis in labour. Why should a woman with unknown GBS carriage status be denied the opportunity to find out if her baby is at risk?
I would like to pay tribute to the tireless work of Group B Strep Support, the charity and campaign group that has been working to raise awareness of this issue and reduce the death toll. I also have a constituent who has sadly lost a baby to GBS. The group has been a great help to me in preparing for this debate following a meeting with my constituent. Ten years ago, my right hon. Friend the Prime Minister said in his Adjournment debate:
“Group B Strep Support’s aim, which I support, is for the routine test to be offered to all pregnant women, with those who are found to have GBS at the 35 to 37-week stage being automatically offered intravenous antibiotics.”
He said to the then Minister:
“I hope that the Minister will show great urgency over the issue”.—[Official Report, Date; Vol. 408, c. 267WH.]
My right hon. Friend supported the introduction of routine testing: I echo his sentiments exactly.
I congratulate my hon. Friend the Member for Mid Bedfordshire (Nadine Dorries) on securing this debate and raising this very important issue. The death of a baby is devastating for parents and their families. It is important that we do all we can to minimise the risk of such deaths. My hon. Friend has presented a strong case, but, as I shall set out later, it is equally important that we are guided in our decisions by professional, evidence-based advice to ensure that any action taken does not lead to potentially greater adverse outcomes or unintended consequences.
Group B streptococcus is one of many bacteria that can be present in the human body. It is estimated that about one pregnant woman in five in the UK carries GBS. Around the time of labour and birth, many babies come into contact with GBS and are colonised by the bacteria. Most are unaffected, but a small number can become infected.
If a baby develops group B strep less than seven days after birth, it is known as early-onset group B strep. Most babies who become infected develop symptoms within 12 hours of birth, and it is estimated that about one in 2,000 babies born in the UK develop early-onset group B strep, or about 404 babies a year—my hon. Friend made these points earlier. Most babies who become infected can be treated successfully and will make a full recovery, but even with the best medical care, one in 10 babies diagnosed with early-onset group B strep will unfortunately die.
The infection can also cause life-threatening complications, such as septicaemia, pneumonia and meningitis. One in five babies who survive the infection will be affected permanently. Early-onset group B strep can cause problems such as cerebral palsy, deafness, blindness and serious learning difficulties, and rarely can cause infection in the mother—for example, an infection in the womb or urinary tract, or more seriously an infection that spreads through the blood, causing symptoms to develop throughout the whole body.
It is worth reflecting on how the UK compares internationally on rates of group B strep. The reported rate per 1,000 births is 0.38 in the UK; in the USA, where there is testing, it is 0.41; in Spain, 0.39; in France, 0.75; in Portugal, 0.44; and in Norway, 0.46. Even in comparison with countries where there is routine group B strep screening at 35 to 37 weeks, therefore, the UK has relatively low levels of group B strep.
It is also worth setting out some of the general improvements in maternity care that are helping to reduce group B strep and improve the quality of care available to women. We all agree that women should receive high-quality and safe maternity services that deliver the best outcomes for them and their baby. Maternity services feature prominently in the key objectives set out in the first mandate between the Government and NHS England. As set out in the mandate, we want all women to have a named midwife responsible for ensuring she has personalised, one-to-one care. To help deliver that, there has been significant investment in the maternity work force. Since May 2010, the number of full-time equivalent midwives has increased by 6.5%—just under 1,500—and in addition there are currently in excess of 5,000 midwifery students in training. There has, therefore, been considerable investment in maternity services to ensure much more personalised care and, consequently, much safer care for women and their babies.
For the reasons I highlighted, we know that the risk-based strategy is not working effectively. Does the Minister not agree that in countries that have routine testing the chances are greatly improved? He drew comparisons with the US, France and other countries, but we do not know what their figures would be if they were using our risk-based strategy. The fact is that they are routinely testing, so does he not agree that only if we were also routinely testing could we make a like-for-like comparison with other countries? Also, why specifically does the UK, a sophisticated country with sophisticated maternity services, not routinely test?
I will come to those points a little later, but I will try to reassure my hon. Friend. Given that the majority of babies who die from group B strep are born prematurely, testing at 35 to 37 weeks would not benefit them. Tragically, they would have died in any case, so the screening test to prevent them from dying would not have been effective. I will say a little more about that later, if she will allow me to make some progress.
I pay tribute to my hon. Friend for raising this issue, because the first challenge is to raise general awareness of group B strep among the health care work force and women more generally. The Department of Health is working with the NHS, the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives, the National Institute for Health Research health technology assessment team and the pharmaceutical industry to raise awareness of group B strep and reduce the impact of this terrible infection. The Royal College of Obstetricians and Gynaecologists has produced an information leaflet for women who are expecting a baby or planning to become pregnant, and this sets out information about group B strep infection in babies in the first week after birth and the current UK recommendations for preventing group B strep in newborn babies. In addition, information is also available on the NHS Choices website.
As hon. Friends will agree, the focus must be on preventing early-onset group B strep infection from occurring in the first place. The Royal College of Obstetricians and Gynaecologists published updated guidelines on prevention of early-onset group B strep infection in neonates in July 2012, which takes into account the latest evidence. It is important that services undertake local clinical audits to ensure the effective use of intrapartum antibiotic prophylaxis as recommended by the guidance. Following the publication of the revised guidance, the UK national screening committee suggested a formal audit of practice to establish how well the new guidance is being implemented at a national level.
The RCOG, in partnership, with the London School of Hygiene and Tropical Medicine, has now appointed a clinical research fellow to carry out a one-year audit across the UK, which will undertake a review to see how units have revised and updated their local protocols since 2006, using well-designed case studies to gather specific information about maternity unit policies by asking clinicians whether they would screen for group B strep and/or other intrapartum antibiotic prophylaxis in the circumstances described. It will also assess the extent to which current maternity information systems are able to provide data on whether women have had an antenatal culture for group B strep, whether women have been given intrapartum antibiotics and, if so, the antibiotics prescribed, the dose and duration and whether the women had particular risk factors such as intrapartum fever. The audit aims to provide feedback and advice to all participating trusts about how they could further improve their adherence to the RCOG guidelines on the prevention of neonatal group B strep disease.
Clinical audit is a tool that is incredibly valuable in improving the quality of patient care. It is something that trusts do very often on an ad hoc basis. The fact that we now have a national audit focused on group B strep disease will help to standardise practice across all maternity settings and improve the quality of care that is available, so that we can look at which women are more vulnerable and susceptible to developing group B strep and, therefore, reduce infection rates.
That is encouraging news but again the focus is on women who are at risk of group B strep. I am advocating that all women should be tested for group B strep. I recommend that every pregnant woman I meet now buys a kit to test for group B strep. It is encouraging and positive to hear what my hon. Friend the Minister is saying but it is still focusing on the at-risk women, which is what the risk strategy does now. We need to move from that and away from the at-risk women. We need to move from 35 to 37 weeks and forward to full-term and routine testing of all women for group B strep.
I am hopeful that the audit by the RCOG nationally—something I discussed with the group B strep groups and the chief medical officer at a meeting this time last year to progress the work at a greater pace—will put us in a better position to understand in particular which women are at high risk, whether birth units are picking up on those women in a timely manner and how we can improve the situation throughout the country. In the past there has been quite a lot of variation in practice, broadly based on the RCOG guidelines, but it is important—knowing the devastating effects of this illness—that we put together a comprehensive audit tool that gathers data at a national level so we can spread good practice and good guidance throughout. If my hon. Friend will be patient I hope to address some of the broader issues about screening later.
Earlier, my hon. Friend said that some countries that screen have higher rates of group B strep than we do. Does he have any data—he could perhaps write to my hon. Friend the Member for Mid Bedfordshire (Nadine Dorries) and myself—to show what the progression has been since testing was introduced in those countries? I think my hon. Friend the Member for Mid Bedfordshire said that it was falling in Spain but it would be interesting to see how it is moving following the introduction of widespread testing.
I would be delighted to do so. It is important to consider the confounding factors that arise in any research. For example, there is some evidence of different rates of carriage of group B strep among different population groups. Also, the clinical treatment of the disease in hospitals—which is separate from the screening process—can vary from country to country. We have to set the data alongside other practices that take place at local level in order to interpret them in the right way. I would be delighted to write to my hon. Friends, and to any other hon. Members who are interested, with that broader general information.
I shall turn now to the question of routine screening for group B strep. The UK national screening committee advises Ministers and the national health service in all four countries on all aspects of screening policy, and supports implementation. At its meeting on 13 November 2012, the screening committee recommended that antenatal screening for group B strep carriage at 35 to 37 weeks should not be offered, as my hon. Friend the Member for Mid Bedfordshire has pointed out. That is the reason for the debate. The reasons given included the fact that the currently available screening tests cannot distinguish between women whose babies would be affected and those that would not. As a result, about 140,000 low-risk pregnant women would be offered antibiotics in labour following a positive screening test result. The overwhelming majority of those women would have a healthy baby without screening and treatment. In other words, a woman who had screened positive for group B strep at one point in her pregnancy might not necessarily be carrying it at the time of delivery, and up to 140,000 women a year could be given antibiotics during labour even though they did not need them.
On the back of the evidence, concern was also expressed, understandably, about resistance to some of the antibiotics used to prevent early-onset group B strep, about the long-term effects on the newborn and about the potential for anaphylactic reactions in labour. Many of us will recall the report of the chief medical officer for England, in which she expressed particular concern about the risks posed by antibiotic resistance because of overuse. The use of antibiotics on that size of population could create a risk of resistance developing, which would have adverse consequences.
I am interested in what the Minister has just said. As I mentioned in my speech, we are talking about a penicillin, a narrow-spectrum antibiotic. I know the Minister’s background, and he will know that GPs would prescribe it for a throat infection. This is a widely and commonly used antibiotic. Does he not think that these expressions of concern are over-egging the pudding slightly?
In the report that the chief medical officer published earlier this year, she made the point graphically that the overuse of antibiotics among people who do not need them can lead to resistance developing in bacteria. We know from hospital super-bugs such as MRSA and VRSA that many other resistant strains of bacteria are developing. Part of the challenge is to see responsible prescribing adopted more broadly across the NHS, to ensure that antibiotics are being targeted at the people who will benefit directly from them. The chief medical officer’s concern is that the screening that my hon. Friend is proposing could lead to many tens of thousands of women being given antibiotics inappropriately at the time of delivery, because they were not carrying group B strep at the time, and that that could result in resistance developing. We already know about the devastating consequences of group B strep infection, and the development of further resistant strains could be an unintended consequence of such screening that none of us would want to see. We need to be mindful of that possibility, as I believe the national screening committee was when it made its recommendations.
The majority of babies who die from early-onset group B strep are premature and are, sadly, born too early to be helped by screening at 35 to 37 weeks. Data from 2001 show that, in that year, there were 39 deaths due to group B strep, of which 25 occurred prematurely—that is, before the 35th week of pregnancy, when any screening would have been carried out. Those deaths would therefore not have been prevented by a screening programme.
It has been estimated that up to 49,000 women carrying GBS at 35 to 37 weeks of pregnancy may no longer be carriers when receiving treatment during labour. Studies of the test suggest that between 13% and 40% of screen-positive women will no longer be carriers at the point of delivery. There is also a potentially detrimental impact on maternity services, increasing the medicalisation of labour, with the increase in hospital births and increases in the birth rate that we are seeing. We know that once there is one intervention in labour, it can lead to other interventions and a high rate of Caesarian section when it might not have been necessary in the first place. I am not saying that that would always be the case and absolutely not with GBS—far from it—but we know that when a woman enters a medicalised pathway in a maternity unit, it can often lead to interventions that might otherwise have been unnecessary and that are sometimes quite distressing for the woman during labour. This is particularly the case when many of the women potentially put on prophylaxis would no longer be carriers of GBS.
The advice from the UK national screening committee is consistent with that of the Royal College of Obstetricians and Gynaecologists and the National Institute for Health and Care Excellence. I believe we have talked through a number of the issues about why that recommendation was made.
In the brief time remaining, it would be worth mentioning some of the research that is going on. It is estimated that a vaccine for GBS is approximately five years away from development. First-stage trials have now been undertaken, and wider population-based studies for safety and efficacy are in place in high-prevalence areas such as South Africa. I am sure we would all agree that a vaccine would be a very effective solution to GBS, and I shall certainly do all I can to push and nudge to make sure that such a vaccine is brought forward in as safe and appropriate and as timely a manner as possible.
Is the Minister informing us that that vaccine would be widely available? Let me ask him once more—after everything he has said today, for which I am incredibly grateful—why does he think countries like Spain, the United States and others have introduced routine testing when we still seem to be opposed to it?
It is sometimes difficult to explain variations in clinical practice and the care of women during maternity services between different states or within regions of countries like Spain and to understand why they are different from what we have in this country. Here we have robust guidelines in place for trying to identify at-risk women and we are trying to tighten them through audit while we have low rates. I am not sure whether the same can always be said elsewhere in the world. That is why other countries might have wanted to introduce a cruder tool through a screening test to help them reduce their rates. As I have said, I will look further into this matter and write to my hon. Friends in order better to inform them.
Research and clinical audit are important. We want to make sure that we have a proper national audit programme to carry out and develop good and better practice guidelines for GBS. Looking forward to a vaccine, we hope that that will be a long-term answer to this devastating disease, not just for the UK but throughout the world. Prioritising other research studies is also important. At the moment, a study is being carried out by the maternal health and care policy research unit. It is looking at women with GBS sepsis, which will help us understand the physical impact that GBS has on women’s health. A second study looks at providing information at a national level on the numbers of women and babies affected by anaphylaxis due to antibiotic use in labour for GBS or presumed GBS infection. As I mentioned, one concern about a blanket prophylaxis would be the potential anaphylactic reaction that we know can occur when someone is allergic to penicillin or other antibiotics.
I thank my hon. Friend the Member for Mid Bedfordshire once again for raising this important issue. I hope I have been able to clarify some of the reasoning behind the national screening committee’s decisions. I will write to and engage further with my hon. Friend and others to reassure them again that the Government take this issue very seriously. Together, I know we will get to a better place so that fewer families are affected by this tragic illness.
Question put and agreed to.