Can expectant management improve perinatal survival?

The study was a randomized clinical trial conducted at 8 tertiary teaching hospitals in Latin America. Pregnant women at 28-33 weeks’ gestation with severe preeclampsia, severe gestational hypertension, or chronic hypertension with superimposed preeclampsia were included. Grouping these diagnoses allowed inclusion of a larger number of women with significant hypertensive disease. However, the authors acknowledged, and journal participants agreed, that distinctions between the underlying pathophysiology in these groups may affect pregnancy outcomes.

Patients were delivered 24-72 hours after administration of glucocorticoids and magnesium sulfate was continued until 24 hours postpartum in the prompt delivery group. In the expectant management group, which remained under close monitoring, delivery occurred at 34 weeks of gestation or when specific maternal or fetal indications demanded earlier intervention. The primary outcome was perinatal (fetal and neonatal) mortality.

Figure 1 shows a Consolidated Standards of Reporting Trials (CONSORT) flow diagram, which is a standardized depiction of study participants’ passage through trial enrollment, allocation, follow-up, and analysis. The diagram shows that 3 women in the expectant management group did not complete the study and were excluded from the analysis. Two Journal Club participants pointed out that 2 of these patients, who refused to stay in the hospital, should have been included in the intention-to-treat analysis, since patients’ inability to comply with expectant management could impact maternal and neonatal outcomes. Even with this omission, the sample size in both groups was large enough to preserve statistical power.