If his Department will take steps to introduce the enriched culture medium test for group B streptococcus for pregnant women; and if he will make a statement.

As my right hon. Friend will be aware, the UK National Screening Committee is reviewing the evidence for antenatal screening, including the use of enriched culture medium tests for group B streptococcus, following a public consultation. I understand that its recommendation will be published very soon, and I assure him that I will consider the recommendation very carefully and write to him with my view.

My hon. Friend will be aware from his reading of the British Paediatric Surveillance Unit report that the incidence of group B strep has increased by 30% over the last 15 years. Does he agree that this matter has gone on for far too long, and that the Government must come to a conclusion to prevent further tragedies?

My right hon. Friend will be aware that Public Health England published a paper in June 2015 precisely on this subject, but it concluded that within the currently accepted clinical guidelines there are no clinical indicators for testing women using enriched culture medium methods. This test is not, therefore, recommended for routine use at present.

The Department takes advice on all aspects of screening from the independent UK National Screening Committee (UK NSC). The UK NSC is currently reviewing its recommendation on antenatal screening for Group B Streptococcus carriage as part of its three yearly review cycle. A public consultation is currently open and will be closing on 25 January. The UK NSC will consider the evidence and consultation responses at its meeting in February 2017.

The Gold Standards Framework Centre that was developed by Dr Keri Thomas is a private, non-profit organisation that provides training to National Health Service and care home staff in improving the quality of end of life care. There is not an equivalent gold standard framework for detecting group B streptococcus (GBS) infection.

The Enriched Culture Medium (ECM) test is used for detecting GBS carriage at 35-37 weeks of pregnancy and is included in Public Health England’s UK Standards for Microbiology Investigations: Detection of Carriage of Group B Streptococci. In June 2015, Public Health England, in response to requests to introduce the ECM test into Public Health England laboratories, published an advisory position paper which sets out that within current accepted clinical guidelines, there are no indications for testing women using ECM methods. The position paper is available on the gov.uk website at:

https://www.gov.uk/government/publications/group-b-streptococcus-infection-enriched-culture-medium-test

The UK National Screening Committee (UK NSC), the body which advises Ministers in all four United Kingdom countries on all aspects of screening, recommended in 2012 that antenatal screening for GBS carriage at 35 -37 weeks of pregnancy should not be offered because currently there is insufficient evidence to demonstrate that the benefits to be gained from screening would outweigh the harms. The UK NSC is currently reviewing its recommendation on antenatal screening for GBS carriage. A public consultation on the UK NSC’s review opened on 28 October 2016 and will close on 25 January 2017. A copy of the consultation is available at:

https://legacyscreening.phe.org.uk/groupbstreptococcus

A recommendation is expected from the UK NSC following its meeting in February 2017.

Information is not available centrally on laboratory costs.

In June 2015, Public Health England (PHE), in response to requests to introduce the enriched culture medium (ECM) test into PHE laboratories, advised and published a position paper which sets out that within current accepted clinical guidelines, there are no indications for testing women using ECM methods. The position paper is available on the gov.uk website at:

https://www.gov.uk/government/publications/group-b-streptococcus-infection-enriched-culture-medium-test

The UK National Screening Committee’s most recent evidence review estimated that in a population of 776,352 pregnant women, which includes those delivering at term and preterm, there would be approximately 163,000 carriers of group B streptococcus (GBS) at the point of delivery. If all carriers were untreated there would be about 450 cases of early onset GBS equivalent to 0.3% of babies born.

Information about the number of women receiving preventative treatment for GBS is not collected centrally.

The Royal College of Obstetricians and Gynaecologists published a revised green-top guideline in 2012 on the prevention of early onset neonatal group B streptococcal (GBS) disease. The purpose of the guideline is to provide guidance for obstetricians, midwives and neonatologists on the prevention of early onset neonatal GBS disease. It recommends offering intrapartum penicillin prophylaxis to women with a risk factor that is associated with invasive GBS disease in their newborn baby. These are:

- previous baby with invasive GBS infection

- GBS bacteriuria in the current pregnancy

- vaginal swab positive for GBS in current pregnancy

- pyrexia (>38 °C) in labour

- chorioamnionitis

In addition the National Institute for Health and Care Excellence has published a clinical guideline which addresses early onset GBS and other neonatal infections, ‘Antibiotics for early-onset neonatal infection: Antibiotics for the prevention and treatment of early-onset neonatal infection’ (August 2012). The clinical guideline is available at:

http://www.nice.org.uk/guidance/cg149

My Rt. hon. Friend the former Parliamentary Under Secretary of State for Health (Ben Gummer) met representatives from the charity Group B Strep Support (GBSS) and my Rt. hon. Friend, the Member for Mid Sussex (Sir Nicholas Soames), patron of GBSS to discuss group B streptococcus (GBS) in December 2015.

The Department’s Chief Scientific Adviser held two workshops on 19 September and 20 October this year with leading experts from a wide range of organisations, including the charity GBSS to agree workable research questions on early-onset GBS to improve knowledge of the infection. The first workshop discussed evidence gaps in relation to early-onset GBS and the second workshop developed science-based research questions for funders to consider.

On 17 November officials met with GBSS to discuss recent policy developments including the publication of Safer Maternity Care, and the Maternity Transformation Programme.

The UK National Screening Committee (UK NSC) is currently reviewing its recommendation on antenatal screening for GBS carriage as part of its three yearly review cycle. A public consultation is being held which will close on 25 January 2017. Following the closure of the consultation, the UK NSC will review its recommendation on screening for GBS carriage in pregnancy and a recommendation will be made to Ministers.

The table below provides the number of deaths registered in 2015 to those aged between 28 days and under one year in England and Wales where the underlying cause of death was group B streptococcus (GBS) infection. It is not possible to identify a single underlying cause of death for babies born under 28 days.

It is estimated one in 10 babies born with GBS will die from the infection. Estimates have suggested that GBS will cause long term disability in approximately 25 babies a year.

Number of deaths registered to those aged between 28 days and under 1 year where the underlying cause of death was GBS infection, 2015, England and Wales

Notes:

1. There were 818 deaths registered to those aged between 28 days and one year in England and Wales in 2015.
2. GBS infection can also be recorded under ICD-10 code P39.8 but deaths from other infections specific to the perinatal period can also be coded to P39.8.

Source: Office for National Statistics

Public Health England have been collaborating with researchers in Cambridge on a study assessing the potential cost-effectiveness of maternal group B streptococcus (GBS) vaccination in anticipation of a vaccine becoming available in the coming years. As part of this assessment, the cost of treatment of infants with GBS infection is being evaluated and will be available at the conclusion of the study.

If a baby develops group B streptococcus infection (GBS) infection less than seven days after birth, it is known as early-onset GBS infection. Most babies who become infected develop symptoms within 12 hours of birth.

Symptoms include:

- being floppy and unresponsive;

- not feeding well;

- grunting;

- high or low temperature;

- fast or slow heart rates;

- fast or slow breathing rates; and

- irritability.

Most babies who become infected can be treated successfully and will make a full recovery. However, even with the best medical care the infection can sometimes cause life-threatening complications, such as:

- blood poisoning (septicaemia);

- infection of the lung (pneumonia); and

- infection of the lining of the brain (meningitis).

Early-onset GBS infection can cause problems such as cerebral palsy, deafness, blindness, and serious learning difficulties.

Late-onset GBS infection develops seven or more days after a baby is born. Most commonly the baby presents with sepsis. It is not usually associated with pregnancy. The baby is most likely to have become infected after the birth, for example, they may have caught the infection from someone else. GBS infections after three months of age are extremely rare.

If a baby develops group B streptococcus infection (GBS) infection less than seven days after birth, it is known as early-onset GBS infection. Most babies who become infected develop symptoms within 12 hours of birth.

Symptoms include:

- being floppy and unresponsive;

- not feeding well;

- grunting;

- high or low temperature;

- fast or slow heart rates;

- fast or slow breathing rates; and

- irritability.

Most babies who become infected can be treated successfully and will make a full recovery. However, even with the best medical care the infection can sometimes cause life-threatening complications, such as:

- blood poisoning (septicaemia);

- infection of the lung (pneumonia); and

- infection of the lining of the brain (meningitis).

Early-onset GBS infection can cause problems such as cerebral palsy, deafness, blindness, and serious learning difficulties.

Late-onset GBS infection develops seven or more days after a baby is born. Most commonly the baby presents with sepsis. It is not usually associated with pregnancy. The baby is most likely to have become infected after the birth, for example, they may have caught the infection from someone else. GBS infections after three months of age are extremely rare.

Two cost effectiveness estimates have been made by the health technology assessment. One estimated¹ that screening may be cost effective but recommended more research to evaluate the balance of benefit and harm from screening. The second² estimated that screening was close to current cost effectiveness thresholds. It was uncertain whether screening or risk factor management was the more cost effective option.

The National Institute for Health and Care Excellence³ have been unable to evaluate the cost effectiveness of screening because of a lack of data on key parameters.

Notes:

¹ Colbourn et al. Prenatal screening and treatment strategies to prevent group B streptococcal and other bacterial infections in early infancy: cost-effectiveness and expected value of information analyses.2007. HTA. https://www.ncbi.nlm.nih.gov/pubmed/17651659

² Daniels et al. Cost-effectiveness of rapid tests and other existing strategies for screening and management of early-onset group B streptococcus during labour.2010.HTA.

https://www.ncbi.nlm.nih.gov/pubmed/21078057

³ Antenatal care guideline 2008; https://www.nice.org.uk/guidance/cg62

A number of published studies indicate selective enrichment broth culture of vagino-rectal swabs is superior to non selective plate culture to improve the recovery of group B streptococcus (GBS) and avoid the overgrowth by vaginal and rectal flora. Public Health England is not aware of any studies that have compared these tests’ ability to predict early onset GBS infection.

Studies undertaken¹ to date indicate group B streptococcus could be carried in the gut and genital tract of 20-30% adults. Carriage of the organism in mouth and throat is less well assessed but thought to occur in less than 10% of adults.

Note:

1 Rodriguez-Granger J, Alvargonzalez JC, Berardi A, et al. Prevention of group B streptococcal neonatal disease revisited. The DEVANI European project. Eur J Clin Microbiol Infect Dis 2012; 31(9): 2097-104.

Systematic reviews by National Institute for Health and Care Excellence and the Cochrane Collaboration estimate that intravenous penicillin administered during labour is 80 – 85% effective in preventing early onset group B streptococcus (EOGBS). However both reviews reported that the evidence supporting this was poor. In addition no conclusions could be drawn on the effectiveness of antibiotics in labour in reducing the mortality rate from EOGBS.

Each year there will be about 450 babies affected by EOGBS and about 170,000 women who carry group B streptococcus (GBS) at the point of delivery. Most babies come into contact with GBS during labour and experience no ill effect and are born healthy. The balance of benefit and harm from treating women with preventive antibiotics in labour has not been explored in large studies.

There is currently no GBS Prevention Strategy, The UK National Screening Committee (UK NSC) is actively considering the recommendation on antenatal screening for maternal GBS carriage. A public consultation is currently open and will close on the 25 January 2017. A recommendation is expected in February in 2017. The UK NSC welcomes input onto the consultation.

Systematic reviews by National Institute for Health and Care Excellence and the Cochrane Collaboration estimate that intravenous penicillin administered during labour is 80 – 85% effective in preventing early onset group B streptococcus (EOGBS). However both reviews reported that the evidence supporting this was poor. In addition no conclusions could be drawn on the effectiveness of antibiotics in labour in reducing the mortality rate from EOGBS.

Each year there will be about 450 babies affected by EOGBS and about 170,000 women who carry group B streptococcus (GBS) at the point of delivery. Most babies come into contact with GBS during labour and experience no ill effect and are born healthy. The balance of benefit and harm from treating women with preventive antibiotics in labour has not been explored in large studies.

There is currently no GBS Prevention Strategy, The UK National Screening Committee (UK NSC) is actively considering the recommendation on antenatal screening for maternal GBS carriage. A public consultation is currently open and will close on the 25 January 2017. A recommendation is expected in February in 2017. The UK NSC welcomes input onto the consultation.

The UK National Screening Committee (UK NSC) does not recommend screening for group B streptococcus. In the United Kingdom Public Health England laboratory voluntary surveillance reports show that the early onset group B streptococcus (EOGBS) rate has fluctuated with slight increases in recent years and estimate this has increased from 0.37 to 0.44/1000 live births between 2006 and 2015.

The current UK NSC evidence review estimates that the rate in term women is approximately 0.41/1000 live term births. A 2013 report from the USA reported that the rate in term women was 0.21/ 1000 live births.

Comparison of the rate in term women is important as this is the group that will be affected by screening. However it is difficult to make comparision with areas in which screening has been implemented as the majority do no report EOGBS by gestation.