PHOENIX
Trial question
Is planned early delivery superior to expectant management in patients with late preterm preeclampsia?
Study design
Multi-center
Open label
RCT
Population
901 female patients.
Inclusion criteria: female patients with late preterm preeclampsia from 34 to 37 weeks of gestation.
Key exclusion criteria: decision to deliver within the next 48 hours.
Interventions
N=450 planned delivery (induction of labor, unless there was an additional specific indication for pre-labor C-section).
N=451 expectant management (delivery at 37 weeks of gestation or sooner as clinical needs dictated).
Primary outcome
Composite outcome of maternal death and systolic blood pressure ≥ 160 mmHg
65%
75%
75.0 %
56.3 %
37.5 %
18.8 %
0.0 %
Planned
delivery
Expectant
management
Significant
decrease ▼
NNT = 10
Significant decrease in composite outcome of maternal death and SBP ≥ 160 mmHg (65% vs. 75%; RR 0.86, 95% CI 0.79 to 0.94).
Secondary outcomes
Significant increase in composite outcome of neonatal deaths and perinatal deaths or neonatal unit admissions at 7 days (42% vs. 34%; RR 1.26, 95% CI 1.08 to 1.47).
Significant decrease in patients who progressed to severe preeclampsia (64% vs. 74%; RR 0.86, 95% CI 0.79 to 0.94).
Significant decrease in maternal morbidity (15% vs. 20%; RR 0.76, 95% CI 0.59 to 0.98).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In female patients with late preterm preeclampsia from 34 to 37 weeks of gestation, planned delivery was superior to expectant management with respect to the composite outcome of maternal death and SBP ≥ 160 mmHg.
Reference
Lucy C Chappell, Peter Brocklehurst, Marcus E Green et al. Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. Lancet. 2019 Sep 28;394(10204):1181-1190.
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