Placental Growth Factor Assessment of Women With Suspected Pre-eclampsia

NCT02881073 | Completed DMC

• 1 other identifier: LK001-16
• Study Type: interventional
• Target: 2,313
• Locations: 1 country
• Sites: 7

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

Conditions

Pre-eclampsia; Pregnancy, High Risk; Pregnancy Complications

Keywords

Placental Growth Factor; Maternal Morbidity; Neonatal Morbidity; Pre-eclampsia; Heath Economics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Maternal Morbidity

  up to 6 weeks post delivery

• Maternal Morbidity

  up to 6 weeks post delivery

• Maternal Outcome-

  up to 6 weeks post delivery

• Maternal Outcome

  up to 6 weeks post delivery

• Maternal Outcome

  up to 6 weeks post delivery

Study Arms (2)

Control

NO INTERVENTION

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

ACTIVE COMPARATOR

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

Interventions

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

Maternal plasma PlGF quantification

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Irish Centre for Fetal and Neonatal Translational Research: lead
• National Maternity Hospital, Ireland: collaborator
• Rotunda Maternity Hospital, Dublin: collaborator
• Coombe Women and Infants University Hospital: collaborator
• University College Hospital Galway: collaborator
• Royal Jubilee Maternity Hospital, Belfast: collaborator
• Cork University Maternity Hospital: collaborator
• Univerisy Maternity Hospital, Limerick: collaborator
• University College Cork: collaborator

Study Sites (7)

Royal Jubilee Maternity Hospital

Belfast, Ireland

Location

Cork University Maternity Hospital

Cork, Ireland

Location

Coombe Womens & Infants University Hospital

Dublin, Ireland

Location

National Maternity Hospital

Dublin, Ireland

Location

Rotunda Maternity Hospital

Dublin, Ireland

Location

University College Hospital Galway

Galway, Ireland

Location

University Maternity Hospital Limerick

Limerick, Ireland

Location

Related Publications (3)

• Hayes-Ryan D, Khashan AS, Hemming K, Easter C, Devane D, Murphy DJ, Hunter A, Cotter A, McAuliffe FM, Morrison JJ, Breathnach FM, Dempsey E, Kenny LC, O'Donoghue K; PARROT Ireland trial group. Placental growth factor in assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial (PARROT Ireland). BMJ. 2021 Aug 13;374:n1857. doi: 10.1136/bmj.n1857.

  PMID: 34389547 DERIVED

• Hayes-Ryan D, Meaney S, Nolan C, O'Donoghue K. An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study. Health Expect. 2020 Feb;23(1):75-83. doi: 10.1111/hex.12969. Epub 2019 Oct 2.

  PMID: 31578808 DERIVED

• Hayes-Ryan D, Hemming K, Breathnach F, Cotter A, Devane D, Hunter A, McAuliffe FM, Morrison JJ, Murphy DJ, Khashan A, McElroy B, Murphy A, Dempsey E, O'Donoghue K, Kenny LC. PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol. BMJ Open. 2019 Mar 1;9(2):e023562. doi: 10.1136/bmjopen-2018-023562.

  PMID: 30826791 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Louise C Kenny, PhD, MD

  Irish Centre for Fetal and Neonatal Translational Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 26, 2016
• Study Start: June 29, 2017
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (7)