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Trial record 35 of 56 for:    severe preeclampsia AND weeks of gestation

Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia (PARROT)

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ClinicalTrials.gov Identifier: NCT02881073
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
National Maternity Hospital, Ireland
Rotunda Maternity Hospital, Dublin
Coombe Women and Infants University Hospital
University College Hospital Galway
Royal Jubilee Maternity Hospital, Belfast
Cork University Maternity Hospital, Cork
Univerisy Maternity Hospital, Limerick
University College Cork
Information provided by (Responsible Party):
Irish Centre for Fetal and Neonatal Translational Research

Brief 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


Condition or disease Intervention/treatment Phase
Pre-eclampsia Pregnancy, High Risk Pregnancy Complications Other: Maternal plasma PlGF quantification Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2313 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PARROT Ireland: Placental Growth Factor in Assessment of Women With Suspected Pre-eclampsia to Reduce Maternal Morbidity: a Randomised Control Trial
Actual Study Start Date : June 29, 2017
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881073


Locations
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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, Ireland
Sponsors and Collaborators
Irish Centre for Fetal and Neonatal Translational Research
National Maternity Hospital, Ireland
Rotunda Maternity Hospital, Dublin
Coombe Women and Infants University Hospital
University College Hospital Galway
Royal Jubilee Maternity Hospital, Belfast
Cork University Maternity Hospital, Cork
Univerisy Maternity Hospital, Limerick
University College Cork
Investigators
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Principal Investigator: Louise C Kenny, PhD, MD Irish Centre for Fetal and Neonatal Translational Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Irish Centre for Fetal and Neonatal Translational Research
ClinicalTrials.gov Identifier: NCT02881073     History of Changes
Other Study ID Numbers: LK001-16
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irish Centre for Fetal and Neonatal Translational Research:
Placental Growth Factor
Maternal Morbidity
Neonatal Morbidity
Pre-eclampsia
Heath Economics
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action