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Content ArticleThis cohort study in JAMA Network Open aimed to determine whether US Food and Drug Administration (FDA) warnings to prevent prenatal exposure to valproic acid are associated with changes in pregnancy risk and contraceptive use. The study examined 165 772 valproic acid treatment episodes among 69 390 women and found that pregnancy rates during treatment remained unchanged during the 15-year study, and were more than doubled among users with mood disorder or migraine compared with epilepsy. Contraception use among users was uncommon, with only 22.3% of treatment episodes having a 1-day overlap of valproic acid and contraception use. The authors argue that these findings suggest a need to review efforts to prevent prenatal exposure to valproic acid, especially for clinical indications where risk of use during pregnancy outweighs therapeutic benefit and safer alternatives are available.
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News Article
Local control of NHS screening could jeopardise patient safety
Patient-Safety-Learning posted a news article in News
Patients could be put at risk by plans to allow local NHS bodies to oversee the quality of health screening programmes for diseases such as breast and bowel cancer, experts have suggested. At the moment, NHS England runs the Screening Quality Assurance Service (SQAS) to make sure local organisations comply with national standards, are safe and can be subject to inspections. There are 11 national screening programmes in England, including those for breast, cervical and bowel cancer, plus antenatal and newborn screening, abdominal aortic aneurysm and diabetic eye screening. At the moment, screening programmes must report all safety incidents to the SQAS and the SQAS inspectors visit local sites to pick up urgent issues and make recommendations. Now, a report in the British Medical Journal questions plans by NHS England to allow local bodies to have more control. Sue Cohen, former national lead of screening quality assurance at Public Health England, told the BMJ that devolving responsibility for SQAS to local organisations would be a “retrograde” step. She pointed to previous issues, such as in Kent where a lack of oversight of a cervical screening programme led to women with cancer not being picked up. She said: “If you don’t have a quality assurance service that is properly resourced and has that ability to keep a national view, you will simply not have the oversight of the system and there is a bigger risk of incidents going undetected.” Read full story Source: Medscape News, 22 May 2024 -
Content ArticleThe Thirlwall Inquiry is examining events at the Countess of Chester Hospital and their implications following the trial, and subsequent convictions, of former neonatal nurse Lucy Letby of murder and attempted murder of babies at the hospital. As part of this Inquiry, its Terms of Reference asks: “Whether recommendations to address culture and governance issues made by previous inquiries into the NHS have been implemented into wider NHS practice? To what effect?”. To help inform its work in this area, the Inquiry Legal Team has produced this Table of Inquiries and reviews which have been conducted in England and Wales over the last thirty years. Recommendations from each Inquiry have been set out in a comprehensive table, alongside details of whether or not those recommendations have been implemented.
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Content Article
Saving Babies’ Lives 2024: A report on progress (May 2024)
Patient-Safety-Learning posted an article in Maternity
This is the second ‘saving babies’ lives’ progress report from the Joint Policy Unit. When the first report was published in May 2023, the Unit committed to reassessing progress each year. Through this process it aims to hold government and decisionmakers to account, helping to ensure that saving babies’ lives and tackling inequalities in pregnancy and baby loss are the political priorities they deserve to be. This years report highlights that maternity services need a much more transformative approach from government, that matches the scale and impact of the issue. Maternity services are not on course to meet government ambitions to reduce rates of stillbirth, neonatal death or preterm birth, and there continue to be stark and persistent inequalities in rates of pregnancy and baby loss by ethnicity and deprivation. View a summary version of the report -
Content Article
On 9 January 2024, the All-Party Parliamentary Group (APPG) on Birth Trauma established the first national inquiry in the UK Parliament to investigate the reasons for birth trauma and to develop policy recommendations to reduce the rate of birth trauma. Seven oral evidence sessions took place on consecutive Mondays between 5 February and 18 March 2024 in the House of Commons. The Inquiry was also informed by written submissions which were received following a public call for evidence. The inquiry received more than 1,300 submissions from people who had experienced traumatic birth, as well as nearly 100 submissions from maternity professionals. It also held seven evidence sessions, in which it heard testimony from both parents and experts, including maternity professionals and academics. -
News Article
Whooping cough: Cases up again as five infant deaths reported
Patient-Safety-Learning posted a news article in News
Five babies have died from whooping cough as cases continue to rise in England, health officials have announced. The UK Health Security Agency (UKHSA) reported 1,319 cases in England in March, after just over 900 in February, making the 2024 total nearly 2,800. It fears it could be a bumper year for the bacterial infection. The last peak year, 2016, saw 5,949 cases in England. The infection can be particularly serious for babies and infants. Half of cases seen so far this year have been in the under-15s, with the highest rates in babies under three months of age. The five babies who died this year were all under three months old. Known as pertussis or "100-day cough", the infection is a cyclical disease with peaks seen every three to five years. UKHSA has said a steady decline in uptake of the vaccine in pregnant women and children and the very low numbers seen during the pandemic, as happened with other infections because of restrictions and public behaviour, were both factors. The agency said a peak year was therefore overdue and urged families to come forward to get vaccinated if they had not already. Read full story Source: BBC News, 9 May 2024 -
Content ArticleThis report by the Maternity & Newborn Safety Investigations (MNSI) programme examines findings from 92 of their investigations where safety recommendations were made to midwife-led units in NHS hospital trusts in England. It highlights key learnings and prompts to help trusts to consider how safety risks can be mitigated and drive improvements in care.
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News ArticleNHS staff do not correctly monitor a baby’s heart rate during labour in almost half of cases where serious failings lead to tragedy, a review of maternity care has found. The Care Quality Commission identified that inadequate foetal monitoring occurred in 45 of 92 cases (49%) in which a baby died or suffered serious brain damage while being born in a midwife-led unit in England. The findings show that correct monitoring is “critically important” to ensure care is safe in all maternity units, said Sandy Lewis, the director of the CQC’s maternity and newborn safety investigations (MNSI) programme. It analysed four common failings in the 92 births in a report that is intended to help midwives and doctors improve the quality and safety of care. In one case the investigation team found that “there were likely to have been abnormalities in the baby’s heart rate which were ongoing for a prolonged period of time, which were not identified during intermittent auscultation [monitoring]”. In another, midwives were so busy dealing with a separate emergency on the unit that they failed to monitor the baby at the correct recommended intervals and the woman was left unattended. The 92 incidents involved 62 cases in which the newborn suffered a severe brain injury, 19 in which it was alive at the start of labour but was stillborn and 11 when it died within its first six days of life. Read full story Source: Guardian, 8 May 2024
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Content Article
Abbie experienced a high-risk pregnancy with her twin girls. They were born at 27 weeks gestation and weighed in at just 677g and 500g. After 150 nights in Neonatal Intensive Care Unit (NICU), both of Abbie’s daughters came safely home. In this blog, Abbie highlights the importance of building a trauma-informed, clinical network around women whose babies have spent time in NICU. Drawing on her own experience and insights, she offers suggestions for how midwives, GPs and health visitors can support their mental health postnatally. -
News Article
Unplanned ‘Ozempic babies’ may be harmed by weight-loss drugs
Patient Safety Learning posted a news article in News
Women have been told to avoid using weight-loss drugs to help them get pregnant, as doctors report a rise in surprise “Ozempic babies”. Some women struggling with infertility have unexpectedly become pregnant after being prescribed semaglutide, which is used to treat obesity and type 2 diabetes under the brand names Wegovy and Ozempic. However, scientists have now issued a warning that the weight-loss injections may cause birth defects and should not be used by anyone hoping to become pregnant. Professor Tricia Tan, from the department of metabolism, digestion and reproduction at Imperial College London, said: “Women need to know that these drugs should not be used during pregnancy. You can also see that most of the clinical trials have not included women who are intending to become pregnant. Animal studies did show that the animal babies born to animals who were given these medications had problems.” Read full story (paywalled) Source: The Times, 23 April 2024 -
News Article
Letby to seek permission for conviction appeal
Patient Safety Learning posted a news article in News
Lucy Letby is to apply for permission to appeal against her convictions for the murder and attempted murder of babies in her care. A panel of three judges at the Court of Appeal in London is due to consider the former nurse’s case later. The 34-year-old was handed 14 whole life terms last year. She was found guilty of murdering seven babies and attempting to murder a further six at the Countess of Chester Hospital between 2015 and 2016. Second stage Shortly after her trial ended in August, Letby applied for leave to appeal against her convictions. She lost the first stage of the process, in which a single judge reviewed her arguments as a paper exercise. Letby, originally of Hereford, now has the right to a second stage, which involves renewing her application before a panel of judges at a hearing at the Court of Appeal. Separately to the appeal, Letby is due to be re-tried on one charge of attempted murder, which the jury at her trial was unable to decide on. Read full story Source: BBC News, 2 April 2024 -
News Article
Concerns at Nottinghamshire hospital after baby's sepsis death
Patient Safety Learning posted a news article in News
The parents of a baby who died from sepsis said their son deserved a "fighting chance" after concerns were raised over his care in hospital. Ten-week-old Tommy Gillman was admitted to King's Mill hospital on 7 December 2022 but died the next day. Tommy Gillman, from Coddington, Nottinghamshire, was "extremely unwell" with what proved to be Salmonella Brandenburg meningitis when admitted to the Sutton-in-Ashfield hospital at 12:35 GMT. His assessment was delayed, and then the severity of his condition missed, meaning correct treatment with antibiotics and fluids did not start until 17:00. A coroner's report identified a lack of experienced paediatric nurses and confusion in handovers between staff. "I am not reassured that necessary actions to address these serious issues identified are in place," the coroner said. Sherwood Forest Hospitals NHS Foundation Trust said it welcomed the review and a "rapid" programme of improvements was being worked on. Tamzin Myers and Charlie Gillman said their son deserved "a fighting chance" by getting prompt treatment Read full story Source: BBC News, 17 April 2024 -
Content ArticleTommy Gillman died on 8 December 2022 from sepsis and multi organ failure secondary to Salmonella Brandenburg meningitis. There were missed opportunities to provide him with earlier antibiotics, fluid resuscitation and intensive monitoring from 12.35pm on the 7 December 2022 at Kings Mill Hospital. Once the severity of his illness had been recognised at approximately 17:00 hours on that day, he was provided with prompt treatment for septic shock and meningitis. Sadly however he did not respond to this treatment and died the following day following transfer to Leicester Royal Infirmary. Whilst there were serious missed opportunities to provide earlier treatment of sepsis and meningitis.
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Content Article
Sands is the UK's leading charity working to save babies' lives and support bereaved families. In this blog, Julia Clark and Mehali Patel from the Sands Saving Babies’ Lives research team, draw on their recent Listening Project to illustrate the value of working with bereaved parents. Julia and Mehali argue that hearing and amplifying these unique insights is vital to developing safer, more equitable neonatal and maternity care. -
News Article
Black women in England suffer more serious birth complications, analysis finds
Patient_Safety_Learning posted a news article in News
Black women are up to six times more likely to experience some of the most serious birth complications during hospital delivery across England than their white counterparts, with the figures being described as “stark” and disheartening”, according to analysis. Black women made up 26% of women who experienced the birth complication pre-eclampsia superimposed on chronic hypertension during delivery, despite making up just 5% of all deliveries across England, according to a Guardian analysis of NHS figures for 2022-23. They were six times more likely to experience this pregnancy complication than their white counterparts, who made up 47.2% of these cases despite making up 70% of all deliveries. Read full story Source: Guardian, 8 April 2024 -
News ArticlePre-eclampsia affects between 1% and 5% of pregnant women, but more can be done to inform people about its dangers. While pregnant with her son in 2015, Chipiliro Kalebe-Nyamongo’s pregnancy was generally smooth – until she reached about 33 weeks. She started to develop high blood pressure, and was admitted to hospital to be monitored. It was during this period that Kalebe-Nyamongo became concerned when she didn’t feel her baby’s movements as usual. Read full story Source: Guardian, 8 April 2024
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News ArticleFamilies have been told they will have to prove liability for the harm caused to mothers and children at East Kent Hospitals University Foundation Trust before getting compensation. This is despite the inquiry having examined each case in detail and concluding 45 babies could have survived, while 12 who sustained brain damage could have had a different outcome. It also determined 23 women who either died or suffered injuries might have had better outcomes had care been given to “nationally recognised” standards. However, NHS Resolution – which handles claims for clinical negligence – now says families must prove causation and a breach of duty of care before any compensation can be made. This stipulation has been made even in cases where the inquiry found different treatment would have been reasonably expected to make a difference to the outcome. The investigation into the trust’s maternity care led by Bill Kirkup reported 18 months ago. Speaking to HSJ, its author said: “I am disappointed that East Kent families are facing these problems after everything that has happened to them. Of course, it is true that the independent investigation panel was not in a position to rule on negligence, but we did provide a robust clinical assessment of each case. “I would have hoped that this could be taken into account in deciding to offer early settlement instead of a protracted dispute. It seems sad that a more compassionate approach has not been adopted.” Read full story (paywalled) Source: HSJ, 2 April 2024
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News Article
‘My child was drowning’: life and death on an English maternity ward
Patient Safety Learning posted a news article in News
Norah Bassett was hours old when she died in 2019, after multiple failings in her care. What can be learned from her heartbreaking loss? The maternity unit at the Royal Hampshire county hospital in Winchester was busy the evening when Charlotte Bassett gave birth. When the night shift came on duty, a midwife introduced. “She was very brusque,” Charlotte, 37, a data manager, remembers. “She said, ‘We’ve got too many people here. I’ve got this and this to do.’” Charlotte tried to breastfeed Norah, but she wasn’t latching. The midwife told Charlotte to cup feed her with formula. She didn’t stay to watch. Charlotte poured milk from a cup into Norah’s rosebud mouth. Blood came out. It was staining the muslin. The midwife didn’t seem concerned. “I was drowning my child, who was drowning in her own blood. And there was no one there to say: this isn’t normal,” Charlotte says. The Health Services Safety Investigations Body (now HSSIB but at the time known as HSIB), which investigates patient safety in English hospitals, produced a report into Norah’s care in 2020. One sentence leaped out to Charlotte and her husband James. “An upper airway event (such as occlusion of the baby’s airway during skin-to-skin) may have contributed to the baby’s collapse.” In other words, it was possible that Charlotte might have smothered her daughter. “So Charlotte spent four years in agony,” says James, “thinking it was her.” Dr Martyn Pitman remembers the night Norah died, because it was unusual. A crash call, for a baby born to a low-risk mother. It played on his mind, because eight days earlier, on 4 April 2019, Pitman, a consultant obstetrician and gynaecologist, had presented proposals for enhanced foetal monitoring to a meeting of the maternity unit’s doctors and senior midwives. Pitman, 57, who is an expert in foetal monitoring, felt the proposals would prevent more babies suffering brain injuries at birth. “We’re not that good at detecting the high-risk baby, in the low-risk mum,” he says. Another doctor would later characterise the meeting as “hideous … hands down the worst meeting I’ve ever been to. Martyn … was being set upon.” A midwife felt the animosity in the room was “personal towards Martyn”, and was “appalled” by the “unprofessionalism that I saw from my midwifery colleagues”. James and Charlotte join an unhappy club: a community of parents whose children died young, after receiving poor care, and were told their deaths were unavoidable, or felt blamed for them. “I’ve spoken to so many families,” says Donna Ockenden, who authored a 2022 report into Shrewsbury’s maternity services, “who have been blamed for the eventual poor outcome in their cases. This has included being blamed for their babies’ death.” She has also met the families of women blamed for their own deaths. “This never fails to shock me,” she says. Read full story Source: The Guardian, 26 March 2024 -
News ArticleThe Royal College of Paediatrics and Child Health has called on the UK government not to wait until after the upcoming general election to approve an infant immunisation programme against respiratory syncytial virus (RSV), so that babies can be protected next winter. In June 2023 the Joint Committee on Vaccinations and Immunisations (JCVI) recommended developing an RSV immunisation programme for infants and for older adults.1 It issued a fuller statement reiterating the advice in September 2023.2 But the government has yet to make a final decision on rolling out an RSV immunisation programme. A letter signed by more than 2000 paediatricians and healthcare professionals says that the sooner a full RSV vaccination programme is implemented the more effective it will be and that it “could save child health services reaching breaking point.” Read full story (paywalled) Source: BMJ, 20 March 2024
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News ArticleAn inquest into the death of a baby boy who died two weeks after birth in a Sussex hospital has found there were missed opportunities in the care of his mother. Orlando Davis was born by emergency caesarian section at Worthing Hospital, part of University Hospitals Sussex NHS Foundation Trust, on 10 September 2021 following a normal and low risk pregnancy. He was born with no heartbeat and his parents were told he had suffered an irreversible brain injury after being starved of oxygen - after his mother Robyn Davis experienced seizures during labour, caused by a rare condition that went "completely unrecognised" by staff. Orlando died in Robyn and husband Jonny’s arms on 24 September 2021 at 14 days old due to his catastrophic brain injury. His mother had to be put in an induced coma, but has since recovered. But his parents say his death was avoidable. Today at the inquest into Orlando's death, senior coroner, Ms Penelope Schofield said a lack of understanding of hyponatremia contributed to neglect of Orlando. Mrs Davis had told the inquest: “I can’t explain the sadness, frustration, anger and complete heartbreak I felt and still feel towards the trust for not keeping us safe. Mrs Davis continued: “The thing I cannot process is that I have lost my healthy, full-term son. I feel as if my son was taken from me in a circumstance that, in my personal and professional opinion, was completely preventable. Read full story Source: ITVX, 14 March 2024
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News Article
Parents watched 18 month old die after Shrewsbury hospital failings
Patient Safety Learning posted a news article in News
Alice and Lewis Jones were forced to watch their 18-month-old baby die in front of them after a failure by a scandal-hit NHS trust left him with a “catastrophic brain injury” following his birth. Their son Ronnie was one of hundreds of babies who have died following errors by Shrewsbury and Telford Hospital, where the largest NHS maternity scandal to date was previously uncovered by The Independent. Two years later, Mr and Mrs Jones are calling for the Supreme Court to overturn a controversial decision in February which ruled bereaved relatives could not claim compensation over the psychological impact of seeing a loved one die, even if it was caused by medical negligence. It comes after the trust admitted to failings in a letter to the parents’ lawyers. Ronnie’s birth in 2020 fell outside of the Ockenden review and his parents have warned it showed failures were still occurring despite warnings made during the inquiry. Within the Ockenden inquiry, multiple cases of staff failing to recognise and act upon CTG training were found, and the final report recommended all hospitals have systems to ensure staff are trained and up to date in CTG and emergency skills. The report also said the NHS should make CTG training mandatory and that clinicians must not work in labour wards or provide childbirth care without it. A CTG measures a baby’s heart and monitors conditions in the uterus and is an important measure before birth and during labour to observe the baby for any signs of distress. Ms Jones said: “We knew about the Ockenden review, but everything at Telford was new and so I think we just assumed that lessons had been learned, the same thing wouldn’t happen to us.” Ronnie’s parents are campaigning to reverse the Supreme Court which ruled that “secondary victims” – including parents who are not directly harmed by the birth – are not eligible to bring claims for psychiatric injury following medical negligence. Read full story Source: The Independent, 14 March 2024 -
News ArticleMPs are calling for a new review into the dangers of the drug Primodos, claiming that families who suffered avoidable harm from it have been "sidelined and stonewalled". MPs said the suggestion there is no proven link between the hormone pregnancy test and babies being born with malformations is "factually and morally wrong". A report by the All-Party Parliamentary Group (APPG) on hormone pregnancy tests claims evidence was "covered up" and it is possible to "piece together a case that could reveal one of the biggest medical frauds of the 20th century". Around 1.5 million women in Britain were given hormone pregnancy tests between the 1950s and 1970s. They were instructed to take the drug by their GPs as a way of finding out if they were pregnant. But Primodos was withdrawn from the market in the UK in the late 1970s after regulators warned "an association was confirmed" between the drug and birth defects. However, in 2017 an expert working group found there was insufficient evidence of a causal association. But MPs now claim this report is flawed. It's hugely significant because the study was relied upon by the government and manufacturers last year to strike out a claim for compensation by the alleged victims. Read full story Source: Sky News, 1 March 2024
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News Article
Baby death inquiries are poor and incomplete, experts say
Patient Safety Learning posted a news article in News
Deaths of newborn babies should be more thoroughly investigated by health boards in Scotland, experts have said after reviewing an increase in infant mortality. The team found inquiries into baby deaths conducted by health boards were “poor quality, inconsistent and incomplete”. The experts added that information about staffing levels on maternity wards at the time of the deaths was so poor that they could not draw any conclusions. They were also unable to determine if health boards enlisted independent, external advisers when considering if deaths could have been prevented. Helen Mactier, a retired neonatologist and chairwoman of the Neonatal Mortality Review, said: “This review has helped to get a clearer understanding of the increase in neonatal deaths that occurred in 2021-22. “We understand that there are still unanswered questions, and our recommendations are focused on ensuring that future opportunities to learn are not missed and acted on in a timely and comprehensive manner.” Read full story (paywalled) Source: The Times, 27 February 2024 -
News Article
Mums call for Strep B screening to save babies
Patient Safety Learning posted a news article in News
Mothers of babies who died or suffered brain damage from a Group B Strep (GBS) infection say routine screening is needed. Oliver Plumb, from the charity Group B Strep Support, said it was a "small number of babies" exposed to the bacteria that developed a serious and potentially fatal infection. He said around 800 babies a year developed the infection - which is about two babies a day - and about one a week will die, while another a week will be left with a lifelong disability. "It's a heart-breaking start to life for families and that often the first they hear of Group B Strep is when their baby is sick or in intensive care". The charity has called for GBS to be a notifiable disease to make it a legal responsibility for infections to be reported. It added that current figures could be "missing around one fifth of the infections". There was a "postcode lottery" in terms of how many families will hear about GBS, he said. The charity also backed calls for screening. "In the UK we don't sadly have a routine testing programme, that's at odds with much of the rest of the high-income world. " A DHSC spokesperson said a public consultation on the notifiable diseases list was carried out last year. "DHSC and UKHSA are considering the responses and confirmation of any changes will be published in due course," they said. Several reasons for not recommending routine screening have been given by the committee, including that results can change in the last few weeks of labour, and that GBS does not cause infection in every baby. Read full story Source: BBC News, 26 February 2024 Further reading on the hub: Leading for safety: A conversation with Jane Plumb, Founder of Group B Strep Support -
Content ArticleDespite its reported benefits, breastfeeding rates are low globally, and support systems such as the Baby Friendly Initiative (BFI) have been established to support healthy infant feeding practices and infant bonding. Increasingly reviews are being undertaken to assess the overall impact of BFI accreditation. A systematic synthesis of current reviews has therefore been carried out to examine the state of literature on the effects of BFI accreditation.
