Abstract
Patients with hypertensive disorders of pregnancy usually have the 2 treatment options, either immediate delivery or continuing the pregnancy. Although immediately delivery of the placenta is seen as the more definitive of the 2 treatments, it does carry the potentially higher risks of an earlier birth (preterm if <37 weeks’
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gestation), neonatal complications, and need for cesarean delivery. In particular, little is known of immediate delivery’s effect on maternal and neonatal outcomes in women between 34 and 37 weeks’ gestation. Therefore, this study, HYPITAT II, examines a cohort of pregnant women with mild hypertensive disorders at 34 to 37 weeks’ gestation, in order to evaluate the outcomes related to immediate delivery versus expectant monitoring (continuing pregnancy). This was an open-label, randomized controlled trial, in which 703 women with mild gestational hypertension, preeclampsia, deteriorating preexisting hypertension, and/or superimposed preeclampsia were examined at 34 to 36 weeks’ gestation. Patients with severe disease were excluded. Within 24 hours of randomization, patients in the immediate delivery group (n = 353) who had a Bishop score of 6 or greater underwent labor induced by amniotomy with oxytocin augmentation, had a score of less than 6, cervical priming prior to induction of labor, or, if they had a contraindication as determined by the attending obstetrician, cesarean delivery. Expectant monitoring (n = 351) was conducted per standard local protocols. Both maternal and neonatal outcomes were observed until discharge, and then patients were followed up at 6 weeks after birth. Primary maternal outcome was a composite of adverse maternal outcomes (thromboembolic complications, pulmonary edema, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, eclampsia, placental abruption, death), whereas secondary maternal outcomes were mode of delivery and cesarean delivery. Primary neonatal outcome was respiratory distress syndrome, whereas secondary outcomes covered a wide range of neonatal complications. The primary neonatal outcome, or respiratory distress syndrome, occurred more frequently in the immediate delivery group than in the expectant monitoring group (5.7% vs 1.7%; relative risk, 3.30; absolute risk, 4.0%; P = 0.005), and in a post hoc analysis, overall risk of neonatal morbidity was higher in the immediate delivery group than in the expectant monitoring group. However, neonates in the expectant monitoring group were at significantly increased risk of admission to the neonatal intensive care unit, infection or sepsis, or transient tachypnea. Although less, the risk of adverse primary maternal outcomes, as a composite, was not statistically significantly different between the 2 groups (1.1% immediate vs 3.1% expectant monitoring; relative risk, 0.36; absolute risk, 2.0; P = 0.067). HELLP syndrome was observed as the most common adverse outcome in both groups. Risk of cesarean delivery between groups also did not differ significantly. None of the adverse maternal outcomes led to neonatal complications. Immediate delivery carries significantly increased risk of adverse neonatal outcomes, such as respiratory distress syndrome. Although women with mild hypertensive disorders at 34 to 37 weeks’ gestation may benefit slightly from immediate delivery, until further studies are conducted to clarify the uncertainty, the authors recommend expectant monitoring as the primary route of treatment for this population and that immediate delivery take place only when needed.
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