Information for Clinicians

What is PARROT Ireland?

PARROT: Placental growth factor in Assessment of women with suspected pre-eclampsia to Reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial.

It is a national multi-site stepped wedge cluster randomised controlled trial involving pregnant women with suspected pre-eclampsia. It is being carried out from June 2017 until December 2018 in 7 of the largest Maternity Hospitals in Ireland. The trial will investigate if adding an extra blood test called placental growth factor (PlGF) to routine care will help diagnose those women with severe pre-eclampsia faster, and weather this reduces complications to these women and their babies from pre-eclampsia. It will also examine the health care cost implications associated with the addition of this extra blood test to routine care.

Clinical Trial.gov Ref: NCT 02881073


What is Placental Growth Factor (PlGF)?

Placental Growth Factor is a protein that is made by the placenta during pregnancy. Women with pre-eclampsia have much lower levels of PlGF circulating in their bloodstream at all stages of pregnancy. Studies have shown that a low PlGF result is a good indicator of which pregnancies will likely develop complications from pre-eclampsia (PELICAN study).

Results of PlGF:


PlGF <12 pg/ml:

Very low        


“Very Low” Is indicative of severe placental dysfunction and very high risk for preterm fetal or maternal complications

 


PlGF ≥12 and <100 pg/ml:

Low

 

 

“Low” Is indicative of placental dysfunction and high risk for fetal or maternal complications including term pre-eclampsia

 


PlGF ≥100 pg/ml:

Normal


'Normal' indicates that placental dysfunction is unlikely and the patient is at low risk of preterm fetal or maternal complications in the next 14 days

 


How are participants randomised?

Participants are not individually randomised rather the maternity unit they are attending is randomised to either control or active management at a given time point.Each unit will begin in the control arm of the trial and each will eventually transition to the active arm at intervals of 2 months so that by the end of the trial all units are in the active arm.


Who is eligible for inclusion?

Any woman between 20-36+6 weeks with suspected PET. Women already with confirmed PET are not eligible for inclusion.


How will the study affect medical decision making?

Knowledge of PlGF result should enable clinicians to stratify women into those that are low risk of PET development and can continue with routine antenatal care and those that are higher risk, in need of increased surveillance, and allow them to focus resources on this group. Potentially a highly abnormal PlGF result may lead the clinician to perform an earlier delivery, leading to increased incidence of induction of labour and reduced maternal morbidity as complications from PET will be lowered. However, lowering the gestational age at delivery may result in increased neonatal morbidity from prematurity related conditions.

Trial Schema:


Who is organising, funding and sponsoring the study?

The study is being run organised and funded though the Health Research Board Mother & Baby Clinical Trials Network Ireland www.hrb-mbctni.ie and the INFANT centre www.infantcentre.ie . It is sponsored by UCC.


Ethical Approval

The local hospital ethics committee at each participating maternity hospital has reviewed and approved the study protocol and patient information sheet.