An interventional study of Maternal plasma PlGF quantification in Pre-eclampsia, Pregnancy, High Risk and Pregnancy Complications, sponsored by Irish Centre for Fetal and Neonatal Translational Research. Completed at 7 sites in Ireland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Irish Centre for Fetal and Neonatal Translational Research · Not applicable, Interventional, and Diagnostic
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
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.
328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.
This study's enrollment of 2,313 is above the median of 120 across 169 interventional studies indexed under Eclampsia.
Browse Eclampsia studies →This is the only study on the registry with Irish Centre for Fetal and Neonatal Translational Research as lead sponsor.
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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
Exclusion Criteria:
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.
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: * PlGF \<12 pg/ml: Very low * PlGF ≥12 and \<100 pg/ml: Low * PlGF ≥100 pg/ml: Normal 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
assessed using a composite outcome combining the modified fullPIERS model for pre-eclampsia with sustained systolic blood pressure ≥ 160 mmHg
Time frame: up to 6 weeks post delivery
Neonatal Morbidity
assessed using a composite neonatal score
Time frame: From neonates birth until time of discharge from the neonatal unit/hospital, up to 6 weeks post delivery
Maternal Morbidity
Final diagnosis of hypertensive disorder of pregnancy
Time frame: up to 6 weeks post delivery
Maternal Morbidity
Maternal morbidity by fullPIERS model (without systolic hypertension)
Time frame: up to 6 weeks post delivery
Maternal Outcome-
Progression to severe pre-eclampsia as defined by ACOG
Time frame: up to 6 weeks post delivery
Maternal Outcome
Caesarean section: emergency or elective
Time frame: up to 6 weeks post delivery
Maternal Outcome
Elective delivery: induction of labour or Caesarean section
Time frame: up to 6 weeks post delivery
Fetal Outcome
Gestation at diagnosis of pre-eclampsia
Time frame: up to 6 weeks post delivery
Fetal Outcome
Fetal growth restriction identified on antenatal ultrasound
Time frame: up to 6 weeks post delivery
Fetal Outcome
Gestation at delivery
Time frame: up to 6 weeks post delivery
Heath Economic Outcomes
Costs to Health Service of Community Based care: assessed through chart review at discharge
Time frame: up to 6 weeks post delivery
Heath Economic Outcomes
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
Time frame: up to 6 weeks post delivery
Fetal Quality of Life Assessment
Use utility values / decrements scale for infants to estimate the cost effectiveness of the intervention
Time frame: up to 6 weeks post delivery
Heath Economic Outcomes -Transport costs to patient of appointments
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.
Time frame: up to 6 weeks post delivery
Maternal Quality of Life
Assessed through EQ-5D-5L questionnaire
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
Maternal Quality of Life
Assessed through SF-6D questionnaire
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
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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