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2: Delivery versus expectant monitoring for late preterm hypertensive disorders of pregnancy (HYPITAT-II): a multicenter, open label, randomized controlled trial

      Objective

      There is limited evidence on the effectiveness of immediate delivery for women with hypertensive disorders in late preterm pregnancy. We evaluated whether delivery could reduce adverse maternal outcomes in this group without compromising neonatal outcomes.

      Study Design

      We conducted a multicenter, open label, randomized controlled trial in 51 Dutch hospitals. It included women with gestational hypertension, preeclampsia or deteriorating chronic hypertension between 34-37 weeks gestation, who were randomly allocated to either immediate delivery, or expectant monitoring. Primary outcomes were a composite adverse maternal outcome (eclampsia, HELLP-syndrome, pulmonary edema, thrombo-embolic disease, placental abruption, and/or maternal death), and neonatal respiratory distress syndrome (RDS). Analysis was by intention to treat.

      Results

      Between June 2009 and March 2013, 754 women were randomized to either planned delivery (n=353) or expectant monitoring (n=351).
      Adverse maternal outcomes occurred in 0.9% of the women in the delivery group and 2.8% in the expectant monitoring group (RR 0.30; 95% CI 0.08-1.08, NNT 51). For women included with gestational hypertension, these rates were 0% vs. 1.9% (RR 0; NNT 53) and for women with preeclampsia 1.5% vs. 3.4% (RR 0.44; 95% CI 0.11-1.67; NNT 53).
      RDS was diagnosed in 6.0% of the infants in the delivery group, compared to 2.0% in the expectant monitoring group (RR 3.01; 95% CI 1.30-6.99; NNH 25). When stratified for gestational age at inclusion, these rates were 13.0% vs. 5.6% (34+0-34+6 weeks), 5.9% vs. 1.5% (35+0-35+6 weeks) and 3.0% vs. 0.7% (36+0-36+6 weeks).

      Conclusion

      In women with late preterm hypertensive disorders of pregnancy, routine delivery did not decrease the risk of severe adverse maternal outcomes, while it increased the risk of neonatal respiratory distress syndrome.