Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia

Pre-eclampsia Clinical Trial

— PARROT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881073
• Other study ID #: LK001-16
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: August 2019
• Source: Irish Centre for Fetal and Neonatal Translational Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2313
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Ireland	Royal Jubilee Maternity Hospital	Belfast
Ireland	Cork University Maternity Hospital	Cork
Ireland	Coombe Womens & Infants University Hospital	Dublin
Ireland	National Maternity Hospital	Dublin
Ireland	Rotunda Maternity Hospital	Dublin
Ireland	University College Hospital Galway	Galway
Ireland	University Maternity Hospital Limerick	Limerick

Sponsors (9)

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

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Morbidity	assessed using a composite outcome combining the modified fullPIERS model for pre-eclampsia with sustained systolic blood pressure = 160 mmHg	up to 6 weeks post delivery
Primary	Neonatal Morbidity	assessed using a composite neonatal score	From neonates birth until time of discharge from the neonatal unit/hospital, up to 6 weeks post delivery
Secondary	Maternal Morbidity	Final diagnosis of hypertensive disorder of pregnancy	up to 6 weeks post delivery
Secondary	Maternal Morbidity	Maternal morbidity by fullPIERS model (without systolic hypertension)	up to 6 weeks post delivery
Secondary	Maternal Outcome-	Progression to severe pre-eclampsia as defined by ACOG	up to 6 weeks post delivery
Secondary	Maternal Outcome	Caesarean section: emergency or elective	up to 6 weeks post delivery
Secondary	Maternal Outcome	Elective delivery: induction of labour or Caesarean section	up to 6 weeks post delivery
Secondary	Fetal Outcome	Gestation at diagnosis of pre-eclampsia	up to 6 weeks post delivery
Secondary	Fetal Outcome	Fetal growth restriction identified on antenatal ultrasound	up to 6 weeks post delivery
Secondary	Fetal Outcome	Gestation at delivery	up to 6 weeks post delivery
Secondary	Heath Economic Outcomes	Costs to Health Service of Community Based care: assessed through chart review at discharge	up to 6 weeks post delivery
Secondary	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	up to 6 weeks post delivery
Secondary	Fetal Quality of Life Assessment	Use utility values / decrements scale for infants to estimate the cost effectiveness of the intervention	up to 6 weeks post delivery
Secondary	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.	up to 6 weeks post delivery
Secondary	Maternal Quality of Life	Assessed through EQ-5D-5L questionnaire	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
Secondary	Maternal Quality of Life	Assessed through SF-6D questionnaire	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