Risks and Benefits of Immediate Delivery in Nonsevere Hypertensive Disorders Between 34-37 Weeks' Gestation

Jul 02, 2015
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Authors:
Broekhuijsen K, van Baaren GJ, van Pampus MG, et al., on behalf of the HYPITAT-II Study Group.
Citation:
Immediate Delivery Versus Expectant Monitoring for Hypertensive Disorders of Pregnancy Between 34 and 37 Weeks of Gestation (HYPITAT-II): An Open-Label, Randomised Controlled Trial. Lancet 2015;385:2492-2501.
Summary By:
Prashant Vaishnava, MD, FACC

Study Questions:

What is the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes for women with hypertensive disorders between 34 and 37 weeks’ gestation?

Methods:

HYPITAT-II was an open-label, randomized, controlled trial conducted in the Netherlands. Eligible women had gestational hypertension, pre-eclampsia, deteriorating pre-existing hypertension, or superimposed pre-eclampsia, and had a gestational age of 34 weeks up to and including 36 weeks. Participants were randomly assigned to immediate delivery or expectant monitoring (with observation as outpatients, through a home care program, or in the hospital). The primary maternal outcome measure was a composite of adverse maternal outcomes, defined as one or more of thromboembolic complications, pulmonary edema, HELLP syndrome, eclampsia, placental abruption, or maternal death. The primary neonatal outcome was neonatal respiratory distress syndrome.

Results:

The analytic sample included 703 patients who were randomly assigned to immediate delivery (n = 352) or expectant monitoring (n = 351). The primary maternal outcome occurred in four (1.1%) of 352 women in the immediate delivery group compared with 11 (3.1%) of 351 women in the expectant monitoring group (relative risk [RR], 0.36; 95% confidence interval [CI], 0.12-1.11; p = 0.067). HELLP syndrome was the most common maternal adverse outcome. The primary neonatal outcome occurred in 20 (5.7%) of 352 neonates in the immediate delivery group versus six (1.7%) of 351 neonates in the expectant monitoring group (RR, 3.3; 95% CI, 1.4-8.2; p = 0.005). No maternal or perinatal deaths occurred.

Conclusions:

In women with nonsevere hypertensive disorders at 34-37 weeks of gestation, immediate delivery was associated with a nonsignificant trend toward fewer adverse maternal outcomes, but was associated with a significant increase in the risk for neonatal respiratory distress syndrome.

Perspective:

This is an important study that provides insight on the risks and benefits of immediate delivery versus expectant monitoring in nonsevere hypertensive disorders between 34 and 37 weeks of gestation. The findings would generally support the authors’ opinion that ‘routine immediate delivery is…not justified and a strategy of expectant monitoring can be considered.’ That said and as the authors acknowledge, the absolute numbers of adverse maternal outcomes were low in both groups and point estimates were wide. Certainly, future studies should help inform best practices in this patient population.

Keywords: Abruptio Placentae, Delivery, Obstetric, Eclampsia, Gestational Age, HELLP Syndrome, Home Care Services, Hypertension, Pregnancy-Induced, Hypertension, Infant, Newborn, Maternal Death, Outcome Assessment, Health Care, Outpatients, Pre-Eclampsia, Pregnancy, Primary Prevention, Pulmonary Edema, Respiratory Distress Syndrome, Newborn, Risk Assessment


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