NCT02881073

Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia

PARROT Ireland: Placental Growth Factor in Assessment of Women With Suspected Pre-eclampsia to Reduce Maternal Morbidity: a Randomised Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,313 (actual)
• Sponsor: Irish Centre for Fetal and Neonatal Translational Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim is to establish the effectiveness of plasma PlGF measurement in reducing maternal morbidity (with assessment of perinatal safety in parallel) in women presenting with suspected pre-eclampsia prior to 37 weeks' gestation. The long term aim is to demonstrate that knowledge of PlGF measurement enables appropriate stratification of the antenatal management of women presenting with suspected pre-eclampsia, such that those at highest risk receive greater surveillance with a decrease in maternal adverse outcomes, and those at lower risk can be managed without unnecessary admission and other interventions, such that the results would influence international clinical practice in antenatal patient healthcare

Detailed description

Pre-eclampsia (PET), a disease of late pregnancy characterised by hypertension and proteinuria, complicates 2-8% of pregnancies and is associated with significant maternal and neonatal morbidity and mortality. Many reports have highlighted the frequent substandard care, often attributed to clinicians not identifying the seriousness of clinical signs suggestive of the disease. Consequently, improvements in prediction of development of PET have the potential to vastly improve clinical outcomes and reduce costs. Placental Growth Factor (PlGF) belongs to the vascular endothelial growth factor (VEGF) family and represents a key regulator of angiogenic events in pathological conditions. PlGF exerts its biological function through the binding and activation of the receptor Flt-1. In PET, it is thought that endothelial dysfunction leads to an increased level of a circulating decoy receptor, known as soluble Flt-1, (sFlt-1), a soluble receptor for both VEGF-A and PlGF. In 2013, the INFANT team were part of an international group that published the first multicentre prospective study (PELICAN) evaluating the use of PlGF in women presenting with suspected PET, which reported high sensitivity (95-96%) and negative predictive value (95-98%) for low PlGF in determining need for delivery for confirmed PET within 14 days. This study suggests that PlGF testing presents a realistic and innovative adjunct to the management of women with suspected PET, especially those presenting preterm.

Conditions

• Pre-eclampsia
• Pregnancy, High Risk
• Pregnancy Complications

Interventions

Type	Name	Description
OTHER	Maternal plasma PlGF quantification	A point of care test performed on maternal plasma, to quantify the level of the protein PlGF (placental growth factor) in the serum of the pregnant woman with suspected pre eclampsia to help the clinician in stratifying the level of further care for her in her pregnancy

Timeline

• Start date: 2017-06-29
• Primary completion: 2019-04-26
• Completion: 2019-04-26
• First posted: 2016-08-26
• Last updated: 2019-08-07

Locations

7 sites across 1 country: Ireland