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NCT Number: NCT02881073

Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Jubilee Maternity Hospital, Belfast, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maternal plasma PlGF quantification

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Maternal Morbidity

    Time frame: up to 6 weeks post delivery

    Final diagnosis of hypertensive disorder of pregnancy

  2. Maternal Morbidity

    Time frame: up to 6 weeks post delivery

    Maternal morbidity by fullPIERS model (without systolic hypertension)

  3. Maternal Outcome-

    Time frame: up to 6 weeks post delivery

    Progression to severe pre-eclampsia as defined by ACOG

  4. Maternal Outcome

    Time frame: up to 6 weeks post delivery

    Caesarean section: emergency or elective

  5. Maternal Outcome

    Time frame: up to 6 weeks post delivery

    Elective delivery: induction of labour or Caesarean section

  6. Fetal Outcome

    Time frame: up to 6 weeks post delivery

    Gestation at diagnosis of pre-eclampsia

  7. Fetal Outcome

    Time frame: up to 6 weeks post delivery

    Fetal growth restriction identified on antenatal ultrasound

  8. Fetal Outcome

    Time frame: up to 6 weeks post delivery

    Gestation at delivery

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Irish Centre for Fetal and Neonatal Translational Research

Other

Collaborators

  • Coombe Women and Infants University Hospital
  • Cork University Maternity Hospital
  • National Maternity Hospital, Ireland
  • Rotunda Maternity Hospital, Dublin
  • Royal Jubilee Maternity Hospital, Belfast
  • University College Cork
  • University College Hospital Galway
  • University Maternity Hospital Limerick

Registry information

Official study title

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

Acronym: PARROT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2016
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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