Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia (PARROT)
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|ClinicalTrials.gov Identifier: NCT02881073|
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 7, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Pre-eclampsia Pregnancy, High Risk Pregnancy Complications||Other: Maternal plasma PlGF quantification||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2313 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||PARROT Ireland: Placental Growth Factor in Assessment of Women With Suspected Pre-eclampsia to Reduce Maternal Morbidity: a Randomised Control Trial|
|Actual Study Start Date :||June 29, 2017|
|Actual Primary Completion Date :||April 26, 2019|
|Actual Study Completion Date :||April 26, 2019|
No Intervention: Control
Eligible women at participating centres prior to roll-out of PlGF testing (as per stepped wedge trial design) will be managed according to HSE/Institute of Obstetrician and Gynaecologists' National Guidelines for 'The management of hypertensive disorders during pregnancy' & "The management of Pre-eclampsia" or by NICE guidelines for "Management of Hypertension in Pregnancy" for those in Northern Ireland.
Active Comparator: Maternal plasma PlGF quantification
Women in the interventional arm will have an additional point of care test performed at the time of enrolment for immediate PlGF quantification. The PlGF measurement will be reported as the absolute value in pg/ml with the following ranges given:
All hospitals will follow National Guidelines for 'The management of hypertensive disorders during pregnancy' & "The management of Pre-eclampsia" with the additional integration of PlGF results as indicated in the algorithm.
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
- Maternal Morbidity [ Time Frame: up to 6 weeks post delivery ]assessed using a composite outcome combining the modified fullPIERS model for pre-eclampsia with sustained systolic blood pressure ≥ 160 mmHg
- Neonatal Morbidity [ Time Frame: From neonates birth until time of discharge from the neonatal unit/hospital, up to 6 weeks post delivery ]assessed using a composite neonatal score
- Maternal Morbidity [ Time Frame: up to 6 weeks post delivery ]Final diagnosis of hypertensive disorder of pregnancy
- Maternal Morbidity [ Time Frame: up to 6 weeks post delivery ]Maternal morbidity by fullPIERS model (without systolic hypertension)
- Maternal Outcome- [ Time Frame: up to 6 weeks post delivery ]Progression to severe pre-eclampsia as defined by ACOG
- Maternal Outcome [ Time Frame: up to 6 weeks post delivery ]Caesarean section: emergency or elective
- Maternal Outcome [ Time Frame: up to 6 weeks post delivery ]Elective delivery: induction of labour or Caesarean section
- Fetal Outcome [ Time Frame: up to 6 weeks post delivery ]Gestation at diagnosis of pre-eclampsia
- Fetal Outcome [ Time Frame: up to 6 weeks post delivery ]Fetal growth restriction identified on antenatal ultrasound
- Fetal Outcome [ Time Frame: up to 6 weeks post delivery ]Gestation at delivery
- Heath Economic Outcomes [ Time Frame: up to 6 weeks post delivery ]Costs to Health Service of Community Based care: assessed through chart review at discharge
- Heath Economic Outcomes [ Time Frame: up to 6 weeks post delivery ]Costs to Health Service of inpatient/day case care: Assessed by chart review at discharge thought HIPE/HPO/Length of stay for both mother and baby
- Fetal Quality of Life Assessment [ Time Frame: up to 6 weeks post delivery ]Use utility values / decrements scale for infants to estimate the cost effectiveness of the intervention
- Heath Economic Outcomes -Transport costs to patient of appointments [ Time Frame: up to 6 weeks post delivery ]Identified 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 Life [ Time Frame: Assessed 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 delivery ]Assessed through EQ-5D-5L questionnaire
- Maternal Quality of Life [ Time Frame: Assessed 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 delivery ]Assessed through SF-6D questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881073
|Royal Jubilee Maternity Hospital|
|Cork University Maternity Hospital|
|Coombe Womens & Infants University Hospital|
|National Maternity Hospital|
|Rotunda Maternity Hospital|
|University College Hospital Galway|
|University Maternity Hospital Limerick|
|Principal Investigator:||Louise C Kenny, PhD, MD||Irish Centre for Fetal and Neonatal Translational Research|