ABSTRACT: Preeclampsia occurs in ∼2% to 12% of all pregnancies, and early severe preeclampsia accounts for ∼25% of all cases. The only known treatment for preeclampsia is delivery, yet an early preterm delivery increases the risk for adverse neonatal outcomes. This randomized, multicenter, parallel, open-label clinical trial was undertaken to determine whether expectant management of severe preeclampsia at less than 34 weeks’ gestation results in better perinatal outcomes compared with prompt delivery (PD) after steroid administration.
Pregnant women with severe hypertensive disorders at 28 to 33 weeks’ gestation were randomly allocated to the PD or expectant management (EXM) group. Prompt delivery patients received glucocorticoid therapy followed by delivery in 24 to 72 hours. Patients in the EXM group were treated with glucocorticoid therapy followed by delivery only for specific maternal/fetal indications or reaching 34 weeks’ gestation. The primary outcome was perinatal mortality (fetal and neonatal death). Secondary outcomes were composite neonatal morbidities, neonatal birth data, and maternal morbidities and death.
Of 267 women, the final cohort included 131 patients (138 births) in the EXM group and 133 (137 births) in the PD group. The 2 groups did not differ significantly in baseline characteristics. Reasons for delivery in the EXM group were uncontrollable blood pressure (40.4%), fetal compromise (29%), persistent symptoms (28.2%), reaching 34 weeks’ gestation (26.0%), and maternal complications (21.3%). Perinatal mortality rates were 9.4% in the PD group and 8.7% in the EXM group, not a significant difference. Composite neonatal morbidities were 56.4% in the PD group and 55.6% in the EXP group (relative risk, 1.01; 95% confidence interval, 0.81–1.26; P = 0.89). The PD group had lower birth weights at delivery (1543 ± 438 vs 1659 ± 509 g), but the EXM group had more small-for-gestational age infants (13 [9.4%] vs 30 [21.7%]; P = 0.005) and abruptio placentae (2 [1.5%] vs 10 [7.6%]; P = 0.01). Rates of total neonatal morbidity and mortality stratified by gestational age at randomization were 85% (63/75), 66.3% (65/98), and 36.2% (37/102), respectively, for 28 to 29 weeks, 30 to 31 weeks, and 32 to 33 weeks, with no significant differences between the PD and EXM groups.
The average pregnancy prolongation in the EXM group was 10.3 ± 8 days compared with 2.2 ± 0.8 days in the PD group (P = 0.0001). No maternal deaths occurred. Oral antihypertensive medications to maintain blood pressure at less than 160/110 mm Hg were used in 61 women (46.5%) in the EXM group. No significant differences in perinatal mortality were noted between women with or without oral antihypertensive medications (7 [11.48%] vs 5 [7.14%]; P = 0.29). The incidence of severe hypertension was 41% and 38.6% in these 2 groups, respectively (P = 0.81). Five women in each oral antihypertensive group had abruptio placentae. Higher maternal morbidity (37.7% vs 14.3%; P = 0.02) was found in the EXM group receiving oral antihypertensive medications.
The only curative treatment for severe preeclampsia is delivery of the fetus. At very early preterm, the consequences of neonatal prematurity must be weighed against potential maternal morbidity by prolonging gestation. The most important factors for improved neonatal outcome are gestational age on presentation, use of corticosteroids, and providing intensive neonatal care. Severe preeclampsia before 34 weeks should be managed with PD after corticoid administration.
Departments of Obstetrics and Gynecology, Complejo Hospitalario de la Caja de Seguro Social (P.V.-d.G.) and Hospital Santo Tomas (O.R.T.), Panama City, Panama; Departments of Obstetrics and Gynecology, Hospital Carlos Andrade Marin, Quito (A.C.M.), and Hospital Teodoro Maldonado Carbo, Guayaquil (V.Y.C.), Ecuador; Department of Obstetrics and Gynecology, Hospital de Ginecología y Obstetricia del Instituto Materno Infantil, Toluca, México (G.T.); Department of Obstetrics and Gynecology, Hospital de Ginecología y Obstetricia del Instituto Guatemalteco de Seguridad Social, Guatemala City, Guatemala (E.H.); Department of Obstetrics and Gynecology, Hospital Nacional Docente Madre Niño, San Bartolomé, Lima, Perú (A.V.); and Department of Obstetrics and Gynecology, Pennsylvania Hospital, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA (J.L.)