BASELINE Birth Cohort study

By |2023-06-29T14:51:40+01:00May 11th, 2023|

The BASELINE Birth Cohort study is Ireland’s opportunity to establish a longitudinal birth cohort with the potential to answer important questions in the study of diseases in early life, later childhood and beyond. It has the potential to identify risk factors for common disorders such as diabetes, eczema, and asthma. This study has the potential to transform the landscape of paediatric research in Ireland.

In 2019/2020 reconsenting of the cohort was undertaken where all parents of participants were sent an updated GDPR compliant consent/assent form and asked to complete and send back to the centre. Approximately 634 replied positively and 25 requested either their data to be removed, their samples to be removed or both, therefore approximately 660 (30%) replied. The INFANT centre continues to store and analyse data and samples from participants who did not reconsent to the BASELINE study as a consent declaration was obtained from the Health Research Consent Declaration Committee (HRCDC) in 2021 which permits the continued storage and processing specifically for the BASELINE study and related research in the absence of reconsenting the participants. The Health Research Regulation (HRR) is also adhered to.

Biosamples and personal data from the study continue to be processed for the purpose of the BASELINE study and are stored securely for future related research which can only be undertaken subject to Ethics Committee approval.

We are continuing to carry out important secondary data analysis of the stored data and biosamples collected from the BASELINE cohort, for example data from the BASELINE study is now being used in the IDEA study.

If you participated in the Baseline Study, you can find out more about your rights in relation to your data here.

Results of PARROT Ireland Trial Published in British Medical Journal

By |2021-08-14T09:50:51+01:00August 13th, 2021|

Results of PARROT Ireland Trial Published in British Medical Journal

Research funded by the Health Research Board Mother and Baby Clinical Trial Network Collaborative Ireland and published by Professor Keelin O’Donoghue in the British Medical Journal, has found that using the Placental Growth Factor test in clinical practice does not improve or worsen outcomes for women and their babies.

A clinical trial involving 2,313 pregnant women has found that using the Placental Growth Factor (PlGF) test does not help Clinicians improve or worsen outcomes for women and their babies.

The potentially dangerous condition pre-eclampsia, which affects between 4-7% of pregnant women, causes high blood pressure and protein in urine, and may in severe cases even lead to the fatality of a mother or baby.

Published in the British Medical Journal  [https://www.bmj.com/content/374/bmj.n1857 ], the findings of the trial do not support the addition of PlGF testing, which had previously in other studies shown promising results in helping to diagnose pre-eclampsia or manage pregnancy complicated by pre-eclampsia.

The results of the national multi-centre trial, which was led by Professor Keelin O’Donoghue [https://www.ucc.ie/en/obsgyn/staff/keelin/], along with investigators from 7 maternity units across Ireland,  from UCC’s world renowned Infant Centre, leaves clinicians without an effective test that can differentiate between women presenting with high blood pressure and those affected by pre-eclampsia.

“At present, we do not have an effective test to tell the difference between women with symptoms of pre-eclampsia, and those that can be managed as an out-patient”.

“High blood pressure is a common problem in pregnancy, affecting about 10-15% of women”.

“Whilst most cases of raised blood pressure are not serious, about 4-7% of pregnant women develop pre-eclampsia”.

Funded by the Health Research Board Mother and Baby Clinical Trial Network Collaborative Ireland, the PARROT Ireland trial was conducted in the seven largest maternity units in Ireland between June 2017 and April 2019.

The trial, which was the largest randomised control trial of PlGF to date, invited women, pregnant with a single baby between 20-36+6 weeks gestation, who had signs or symptoms of pre-eclampsia to take part.

Of the 2,313 women who took part, 1,202 underwent standard hospital tests for suspected pre-eclampsia, while 1,017 had the additional PlGF test performed.

The PlGF test result was given to pregnant women and their clinical teams to help them make decisions on further care and investigations.

Serious complications in mothers, such as; brain, kidney, liver, heart or lung compromise, placental abruption, severe high blood pressure or intensive care admission were recorded, and the results compared between the group that had the test and the group that did not.

Similarly, serious complications in their babies such as lack of oxygen at birth, admission to the neonatal unit, low birth weight, brain, bowel, lung disease or death were also recorded and compared.

The research team continued to engage with the women who took part in the study until both mother and baby were discharged from hospital.

The results of the trial showed that using the PlGF test did not improve or worsen outcomes for women and their babies.

In the end, the results of the 22-month long study did not support the addition of PlGF testing into routine clinical investigations for women presenting with suspected pre-eclampsia.

Funding was provided by the Health Research Board Mother and Baby Clinical Trial Network Collaborative Ireland (HRB-MBCTNI) Grant Number CTN-2014-10.

Link to BMJ Article: https://www.bmj.com/content/374/bmj.n1857

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