Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02881073
Acronym
PARROT
Enrollment
2313
Registered
2016-08-26
Start date
2017-06-29
Completion date
2019-04-26
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia, Pregnancy Complications, Pregnancy, High Risk

Keywords

Placental Growth Factor, Maternal Morbidity, Neonatal Morbidity, Pre-eclampsia, Heath Economics

Brief 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.

Interventions

OTHERMaternal 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

Sponsors

National Maternity Hospital, Ireland
CollaboratorOTHER
Rotunda Maternity Hospital, Dublin
CollaboratorUNKNOWN
Coombe Women and Infants University Hospital
CollaboratorOTHER
University College Hospital Galway
CollaboratorOTHER
Royal Jubilee Maternity Hospital, Belfast
CollaboratorUNKNOWN
Cork University Maternity Hospital
CollaboratorOTHER
Univerisy Maternity Hospital, Limerick
CollaboratorUNKNOWN
University College Cork
CollaboratorOTHER
Irish Centre for Fetal and Neonatal Translational Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pregnant women between 20+0 and 36+6 weeks of gestation (inclusive) Singleton pregnancy Aged 18 years or over Able to give informed consent, presenting with any symptoms of suspected pre-eclampsia * Headache * visual disturbances * epigastric or right upper quadrant pain * increasing oedema * hypertension * dipstick proteinuria * suspected fetal growth restriction * if the healthcare provider deems that the woman requires evaluation for possible pre-eclampsia

Exclusion criteria

* Confirmed pre-eclampsia at point of enrolment (sustained hypertension with systolic BP ≥ 140 or diastolic BP ≥ 90 on at least two occasions at least 4hrs apart) with significant quantified proteinuria (\>300mg protein on 24hr collection, urine protein creatinine ratio \>30mg/mmol or +3 Dipstick Proteinuria) * \>37 weeks gestation * Abnormal PET bloods * Multiple pregnancy at any time point * Decision regarding delivery already made * Lethal fetal abnormality * Previous participation in PELICAN trial in a prior pregnancy * Unable/unwilling to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Maternal Morbidityup to 6 weeks post deliveryassessed using a composite outcome combining the modified fullPIERS model for pre-eclampsia with sustained systolic blood pressure ≥ 160 mmHg
Neonatal MorbidityFrom neonates birth until time of discharge from the neonatal unit/hospital, up to 6 weeks post deliveryassessed using a composite neonatal score

Secondary

MeasureTime frameDescription
Maternal Outcomeup to 6 weeks post deliveryCaesarean section: emergency or elective
Fetal Outcomeup to 6 weeks post deliveryGestation at diagnosis of pre-eclampsia
Heath Economic Outcomesup to 6 weeks post deliveryCosts to Health Service of Community Based care: assessed through chart review at discharge
Maternal Morbidityup to 6 weeks post deliveryFinal diagnosis of hypertensive disorder of pregnancy
Heath Economic Outcomes -Transport costs to patient of appointmentsup to 6 weeks post deliveryIdentified through a costing questionnaire given to the patient to complete at discharge from hospital post delivery. Will ask how far patient lives from their GP and their hospital and their means of transport when attending appointments and thus calculate the transport cost to a patient throughout the pregnancy of attending their appointments.
Maternal Quality of LifeAssessed at two individual timepoints during the trial: once at time of enrolment to the study and repeated again post delivery and up to 6 weeks post deliveryAssessed through EQ-5D-5L questionnaire
Fetal Quality of Life Assessmentup to 6 weeks post deliveryUse utility values / decrements scale for infants to estimate the cost effectiveness of the intervention
Maternal Outcome-up to 6 weeks post deliveryProgression to severe pre-eclampsia as defined by ACOG

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026