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Grand Rounds

RCT Results: Does Including PIGF Testing in Preeclampsia Assessment Reduce Morbidity?

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BACKGROUND AND PURPOSE:

  • Abnormal placental growth factor (PlGF) may be useful as a diagnostic biomarker for preeclampsia, but has yet to be incorporated into guidelines due to lack of evidence regarding clinical utility
  • Hayes-Ryan et al. (BMJ, 2021) assessed whether the addition of PIGF to current clinical practice in the setting of preeclampsia before 37 weeks could improve outcomes

METHODS:

  • Stepped wedge cluster randomized control trial
    • Trial conducted in Ireland
    • Investigator led
    • 7 largest maternity units in Ireland
  • Participants
    • Singleton pregnancy between 20w0d and 36w6d  
    • Signs or symptoms suggestive of evolving preeclampsia
  • Intervention
    • Usual care only
    • Usual care plus point-of-care PlGF testing
  • Study design
    • Each maternity hospital acted as a cluster | All clusters started as a control and then transitioned at random to PlGF intervention at pre-specified time points
    • Usual care: Based upon NICE guidelines for preterm preeclampsia
    • Point-of care PlGF: Increased investigation and frequency of review for abnormal or highly abnormal PlGF result (<100 pg/mL and <12 pg/mL respectively) | Final decisions including when to deliver based on clinician’s judgement
    • Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects by intention-to-treat
  • Primary outcomes
    • Composite maternal morbidity
    • Composite neonatal morbidity

RESULTS:

  • Usual care: 1202 participants | PlGF testing: 1017 participants
  • The addition of point-of-care PlGF testing did not lead to a difference in
    • Maternal morbidity
      • Usual care: 38%
      • PlGF testing: 32%
      • Adjusted risk ratio (aRR) 1.01 (95% CI, 0.76 to 1.36); P=0.92
    • Neonatal morbidity
      • Usual care: 43%
      • PlGF testing: 47%
      • aRR 1.03 (95% CI, 0.89 to 1.21); P=0.67

CONCLUSION:

  • Point-of-care PlGF testing during clinical work-up for women presenting with suspected preterm preeclampsia did not improve maternal or neonatal outcomes
  • The authors conclude that while the results of this study do not support the integration of PlGF testing in clinical assessment, neither do they exclude a potential benefit
  • The authors state

Although we supplied a management algorithm to clinicians to incorporate PlGF based testing into clinical practice, this was a suggested algorithm only and adherence was not mandatory

Fidelity to the algorithm was not assessed. Hence this trial demonstrates a pragmatic evaluation of PlGF based testing effectiveness rather than its efficacy

Learn More – Primary Sources:

Placental growth factor in assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial (PARROT Ireland)

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Related ObG Topics:

Point-of-Care Test for Preeclampsia: Glycosylated Fibronectin
Does Placental Growth Factor Lead to a Quicker Diagnosis in Women with Suspected Pre-Eclampsia?
Follow Up on the PARROT Trial: Is Placental Growth Factor Testing for Preeclampsia Cost-Effective?
Results from the SPREE Trial: How Does First Trimester Preeclampsia Screening Compare to Current Guidelines?

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