Baby deaths coincided with 'unprecedented challenge for NHS'

The independent review was commissioned by Healthcare Improvement Scotland (HIS) on behalf of the Scottish Government, and led by retired consultant neonatologist Dr Helen Mactier in collaboration with a team of medical experts.

The spikes - breaching a control limit - had not been seen before (Image: PHS)

Concerns had been raised after the neonatal mortality rate exceeded Public Health Scotland's upper warning limit twice, in September 2021 and March 2022, for the first time since monthly monitoring had begun in 2017.

Investigators examined all 135 neonatal deaths recorded between April 2021 and March 2022 for any recurring patterns.

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They found higher than expected levels of premature births.

Dr Mactier said this included an increase of "around 40 to 50" in the number born extremely pre-term - before 28 weeks - as well as a "doubling" in the mortality rate for infants born prematurely at 32 to 36 weeks.

Being born pre-term increases the risk of neonatal death, but what caused the rise in premature births and the increase in the mortality rate for those born at 32-36 weeks remains unclear.

"We don't know, is the bottom line," said Dr Mactier.

"But the data we have accords with the increase in perinatal mortality recorded across the whole of the UK during 2021 - that's a combination of stillbirths and neonatal deaths.

"MBRACCE [the surveillance body for maternal and infant mortality across the UK] also reported an 18% increase in pre-term births between 24 and 28 weeks gestation.

"They use slightly different data from us, but effectively the same thing happened across the UK in 2021."

The HIS review does not reach any conclusion on the impact of the pandemic, noting only that the "direct and indirect effects of the Covid-19 pandemic may have contributed, at least in part, to the increase in neonatal mortality".

However, Dr Mactier said it remains a "reasonable hypothesis" that Covid may have driven the increase in premature births given consistent worldwide evidence that the infection is associated with an increased risk of early delivery.

She said: "We just don't have the data within 135 cases to make a definitive conclusion about that, but this was a time of unprecedented challenge for the NHS and also for families in terms of being anxious about going to hospital or staying in hospital.

"There were multiple challenges that were associated with the Covid pandemic so it's plausible that that was the case and, in the absence of another obvious explanation, that does seem very plausible."

Expectant mothers are at higher risk of Covid complications in pregnancy (Image: Getty)

It is unclear whether the mothers involved had been vaccinated against Covid as this information was not available to investigators.

This has led to claims of a cover-up by vaccine sceptics.

Dr Mactier stresses that the comparatively small number of cases involved in the review means it was "never going to be able to address that question" of a vaccine link.

In Scotland, the Covid-19 in Pregnancy in Scotland (COPS) database - which includes 12,808 vaccinated mothers - has found no increased risk of any adverse maternal or neonatal outcome following vaccination, either shortly before or during pregnancy.

Dr Mactier added: "We were never going to address [the vaccine question] because in terms of numbers, it would have been statistically improper.

"But, of the local case reviews that we looked at, Covid vaccination was never mentioned.

"There were seven cases where Covid was mentioned - either because the mother had Covid or there was some staffing challenges attributed to Covid.

"But that was why we didn't look at Covid either. Not because we didn't want to, but because we were never ever going to be powered [in terms of numbers] to make a sensible comment about that.

"The COPS study, and all the other studies around the world, tell women to get immunised. The benefits way outweigh the risks."

The HIS review did highlight shortcomings in relation to the local reviews carried out by health boards into neonatal deaths, describing them as being of "poor quality" and "inconsistent".

Dr Mactier said a lack of resource to enable "proper, external, independent oversight" was the main obstacle.

"What people don't always understand is how incredibly labour intensive a really thorough review is," she added.

However, she stressed that the team were confident based on the information available to them that there was no evidence of systemic failings in NHS care.

She said: "What's important to understand is that this review was never ever planned to look at care in individual cases, so never planned to re-examine individual deaths.

"This was a national review to look for systematic failings in care.

"So although we couldn't get enough data to pick out why the 32-36 weekers seemed to have a doubled mortality, I think there was enough in the reviews to make us fairly sure that there was not some systematic failure of care going on.

"We saw things that could have been done better, as you would predict in any complex healthcare system with humans involved - there's always going to be mistakes.

"But we didn't see anything that kept coming through as something that was new, or something that really stuck out for one unit."