New guidelines to improve pregnancy trials will pave way for novel therapies for women and babies – iNews

A new grading system to monitor complications during clinical trials involving pregnant women will pave the way for novel therapies for women and babies, scientists believe.

The system, co-developed by UCL researchers and an international team of experts, includes new maternal and fetal definitions which the experts say fills a vital gap in pregnancy research for a neglected patient group.

The aim of the grading criteria is to ensure that when complications or emergencies occur in pregnant women participating in clinical trials, such as bleeding or the detection of a new structural abnormality in an unborn baby, it is recorded using a standard definition and then graded on a level of severity to give detailed information about the safety of the intervention being studied.

For the first-in-human or early-phase trials in particular, the grading is vital in determining what dose of medication can be safely offered to mothers.

Dr Rebecca Spencer, who co-led the study said: We believe this new system will greatly improve safety reporting for fetal and maternal clinical trials. Pregnancy research is so important because many of the problems that affect women and their babies during pregnancy still dont have safe and effective treatments. If we are going to do better for future generations then we need to make testing new treatments as safe as possible.

Mehali Patel, from the Stillbirth and Neonatal Death Charity (Sands), said: We often hear from bereaved families about how little was known about what caused their babys death and how few effective treatments were available to make a difference. These guidelines provide researchers with the language they need to open up pregnancy research and increase the potential to develop safe and effective therapies for pregnancy.

The research is published in Prenatal Diagnosis.

Meanwhile, almost a fifth of the most critically ill coronavirus patients in England in recent months were unvaccinated pregnant women, health officials said as they urged expectant mothers to get their jabs. NHS England said that, between July 1 and September 30, 17 per cent of Covid patients receiving treatment through a special lung-bypass machine were mothers-to-be who had not had their first dose of a Covid-19 vaccine.

Data also showed that pregnant women accounted for 32 per cent of all females aged between 16 and 49 in intensive care on extracorporeal membrane oxygenation (ECMO) used when a patients lungs are so damaged by Covid that a ventilator cannot maintain oxygen levels. The figure has risen from 6 per cent at the beginning of the pandemic.

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New guidelines to improve pregnancy trials will pave way for novel therapies for women and babies - iNews

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