A new grading system will monitor complications during clinical trials involving pregnancy, developers have announced.
Researchers at University College, London, UK, working with an international team, say the new system will significantly improve the safety of trials and that of the participating women.
The severity grading system is published in Prenatal Diagnosis and features key definitions and responses for adverse events (AE) that can occur in pregnancy trials. It aims to ensure that, when complications or emergencies occur during clinical trials, they are recorded using a standard definition and then graded on a level of severity.
The 12 maternal and 19 foetal definitions have been adopted by the Medical Dictionary for Regulatory Activities and it is hoped they will go on to be used by triallists, industry and other regulatory authorities.
Lead researcher Professor Anna David, director at UCL Elizabeth Garrett Anderson Institute for Women’s Health and NIHR UCLH BRC, said: “Conducting clinical trials in pregnancy raises many challenges, primarily due to safety concerns for mother and foetus, and particularly when testing novel maternal and foetal therapies.
“We wanted to design a new set of criteria to help all those involved in pregnancy trials so that we can develop new drugs and therapies for women and babies and further advance pregnancy research.”
Dr Gill Norman, a member of the Patient Public Engagement Group who co-developed the criteria, added: “This is an area of medicine where safety concerns are front and centre. Having a framework to record and assess these feels like a big step forward in enabling the testing of different types of treatments for both pregnant women and their unborn babies.
“We hope it will help both the women who decide to take part in trials when pregnant and the clinical staff caring for them.”
The researchers say that using standardised severity grading terminology allows for better comparisons of safety data between clinical trials.
Professor David said the COVID-19 pandemic also highlighted the needs for standardisation.
“A recent example of this phenomenon is the SARS-CoV-2 pandemic, a current and urgent situation in which the exclusion of pregnant and lactating women from many clinical trials of treatment or vaccination for COVID-19 has left a vacuum of information,” she said.
“This means that women and their healthcare providers have to make treatment decisions without the appropriate safety information.”
Study co-leader Dr Rebecca Spencer, NIHR academic clinical lecturer, said the system will greatly improve safety reporting for foetal and maternal clinical trials.
“Pregnancy research is so important because many of the problems that affect women and their babies during pregnancy still don’t 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,” she added.
Spencer RN, Hecher K, Norman G et al. Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Prenatal Diagnosis 22 September 2021
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