Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2019-04-26

Brief Summary

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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

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Detailed Description

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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

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Pre-eclampsia Pregnancy, High Risk Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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:

* 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.

Group Type ACTIVE_COMPARATOR

Maternal plasma PlGF quantification

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No