Minister-backed trial struggling to recruit trusts due to lack of vital test

HSJ understands a meeting earlier this year between health minister Nadine Dorries and charity Group B Strep Support discussed problems facing the GBS3 trial, particularly that many hospitals do not offer enriched culture medium testing and so cannot take part. 

This is despite 2017 Royal College of Obstetricians and Gynaecologists guidance stating ECM testing should be used when checking for GBS. Group B Strep Support says ECM tests for GBS would cost the NHS £11 each.

The GBS3 trial — which the Department of Health and Social Care announced had received ethical approval in 2019 — is investigating whether either ECM testing during the last weeks of pregnancy or a bedside test when labour starts is more effective at reducing newborn group B streptococcus infections compared to the current strategy.

England’s current approach is to offer antibiotics during labour to women who are at increased risk of carrying GBS. The NHS does not routinely test for GBS during pregnancy, although private testing is available. 

GBS3’s deputy chief investigator Kate Walker told HSJ the lack of ECM testing by trusts has “been a big barrier to the GBS3 trial”, although it was “getting better” and there had been some improvement in adoption.

Shortly after the meeting with Group B Strep Support, Ms Dorries told the Commons health and social care committee she had written to all trust CEOs to ensure they are using ECM testing. She added introducing national GBS screening had been “number one” on her list of targets when taking office in 2019.

A readout from January’s meeting between the charity and the minister, which HSJ obtained under the Freedom of Information Act, stated the reasons trusts gave for not using ECM testing included “issues around capacity, automated systems, [and concerns] about extra work involved”.

Dr Walker said laboratories moving to automated systems — which, if not set up for ECM testing, could be difficult to override — presented problems for the trial, as they often serve multiple hospitals. “If one lab says no, then the whole region is unable to take part,” she said.

A readout from a later meeting between the minister and the RCOG, also obtained by HSJ under the FOIA, revealed Ms Dorries was concerned “funding is still a key barrier in trusts signing up”.

Dr Walker said excess treatment costs — where treatment costs for research are higher than those that would be incurred for a patient under normal circumstances — were a barrier for smaller hospitals, which may not incur enough of these costs from other research to meet the threshold to claim back this money from the centre.

So far, 14 trusts are known to be taking part in the trial. GBS3 is aiming to involve up to 80 hospital sites, and HSJ understands the trial hopes to have them all randomised during 2022. The trial is expected to publicly report in 2025. 

Group B Strep Support research, published last December, found of the trusts which offered GBS testing  — for example, to women who had carried the bacteria in a previous pregnancy — only 13 per cent used ECM testing. 

DHSC has described GBS as “the most common cause of life-threatening infection in newborn babies, causing a range of serious infections including pneumonia, meningitis and sepsis”.

According to Group B Strep Support, roughly 800 babies in the UK a year develop GBS infections in their first three months. Of those, 50 babies will die and 70 will have life-altering disabilities.

The latest decision from the UK National Screening Committee  — which advises on population screening — on GBS is from 2017. This decided against routine screening during pregnancy. 

Group B Strep Support policy and public affairs manager Oliver Plumb said hospitals not using ECM testing, and instead opting for a general test “that misses up to half the women carrying GBS and leaves babies at increased risk of a potentially life-threatening and usually preventable GBS infection”, presented “a real challenge for the GBS3 trial”.

A DHSC spokesperson said: “We’re determined to do all we can to protect mothers and babies from [GBS], which is the most common cause of serious infection in newborn babies in the UK.

“While we recognise that maternity services have been under increased pressures in response to the pandemic we are encouraging as many trusts as possible to take part in this important trial.”

HSJ contacted RCOG for comment.