NEW YORK (Reuters Health) – The addition of placental growth factor (PlGF) measurement to usual care of women with suspected pre-eclampsia does not improve maternal or neonatal outcomes, according to results of PARROT Ireland, the largest multicenter randomized controlled trial of PlGF-based testing for women with suspected pre-eclampsia to date.
“Given the lack of maternal or neonatal clinical benefit demonstrated in our trial, we cannot endorse the use of PlGF testing as a diagnostic adjunct to clinical care in women with suspected pre-eclampsia at present and recommend further research be conducted,” researchers write in The BMJ.
Cohort studies have suggested high sensitivity and high negative predictive value of PlGF testing in gauging the need for early delivery in women with suspected pre-eclampsia.
However, there is concern that integrating PlGF testing into routine clinical care may lead to an earlier intervention, lowering gestational age at delivery and increasing problems in newborns.
The PARROT Ireland study, conducted at seven maternity hospitals, enrolled women with a singleton pregnancy between 20 and 36 weeks’ gestation and with signs or symptoms suggestive of evolving pre-eclampsia.
The primary analysis – based on 1,202 women randomly allocated to usual care alone and 1,017 to usual care plus point-of-care PlGF testing – showed no significant difference in maternal or neonatal morbidity with the integration of point-of-care PlGF testing.
“The PARROT Ireland trial shows that integrating a PlGF test into routine investigations for women presenting <37 weeks with a singleton pregnancy and signs/symptoms of evolving pre-eclampsia did not improve or worsen outcomes for women or their babies,” lead author Dr. Deirdre Hayes-Ryan of INFANT Research Centre UCC, Cork University Maternity Hospital, told Reuters Health by email.
“The results add to the information available currently on the impact of PlGF as an interventional test and do not support the use of PlGF testing as a diagnostic adjunct in women with suspected pre-eclampsia,” Dr. Hayes-Ryan said.
“Given the imminent assessment of PlGF testing by the National Institute for Health and Care Excellence (NICE), we recommend urgent reappraisal of the evidence and postponement of updating of guidelines on PlGF testing until an individual participant data (IPD) meta-analysis is performed,” the researchers advise in their paper.
“An IPD meta-analysis of participants from both the UK and Irish PARROT trials is feasible, given both trials employed the same online electronic clinical report form templates and collected the same data points,” they add.
Dr. Hayes-Ryan told Reuters Health that NICE has contacted them in relation to the trial results and it is her understanding that they are currently performing an appraisal of all available research.
SOURCE: https://bit.ly/3k2SCD5 The BMJ, online August 13, 2021.