PARROT Ireland: Placental Growth Factor in Assessment of Women With Suspected Pre-eclampsia to Reduce Maternal Morbidity: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,313
- 试验地点
- 7
- 主要终点
- Maternal Morbidity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Maternal plasma PlGF quantification (Other)
结局指标
主要结局
Maternal Morbidity
时间窗: 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
时间窗: From neonates birth until time of discharge from the neonatal unit/hospital, up to 6 weeks post delivery
assessed using a composite neonatal score
次要结局
- Maternal Outcome-(up to 6 weeks post delivery)
- Heath Economic Outcomes -Transport costs to patient of appointments(up to 6 weeks post delivery)
- Fetal Quality of Life Assessment(up to 6 weeks post delivery)
- Maternal Morbidity(up to 6 weeks post delivery)
- Maternal Outcome(up to 6 weeks post delivery)
- Fetal Outcome(up to 6 weeks post delivery)
- Heath Economic Outcomes(up to 6 weeks post delivery)
- Maternal Quality of Life(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)