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A randomized trial of temporizing management with or without plasma volume expansion in severe and early preeclampsia: maternal morbidity

      Objective

      Preeclampsia, HELLP syndrome, and associated fetal growth restriction (FGR) are important causes of perinatal and maternal morbidity and mortality. Temporizing management until fetal or maternal condition necessitates delivery improves neonatal outcome, without increasing (irreversible) maternal morbidity. The value of plasma volume expansion (PVE) is still debated. We performed an RCT on PVE in severe and early preeclampsia. Here we report on maternal morbidity.

      Study design

      216 patients with severe preeclampsia, HELLP syndrome, eclampsia, or pregnancy-induced hypertension with FGR and a gestational age between 24 and 34 weeks and acceptable fetal condition were randomized for temporizing management with (n = 111) or without (n = 105) PVE (Hydroxy Ethyl Starch 6%, 500 mL daily). Primary outcome was neonatal neurological development at term age and one year post term. An independent monitoring committee used well-defined criteria to determine safety endpoints (maternal and neonatal morbidity and mortality) after case review.

      Results

      Baseline characteristics (age, race, clinical characteristics, and gestational age on inclusion) were distributed equally. Gestational age at inclusion was 29.5 weeks. Mean prolongation of pregnancy (live births) was 11.4 days.
      52 transient maternal complications occurred in 39/216 (18%) patients: maternal death (n = 0), eclampsia (n = 6), liver hematoma (n = 1), renal insufficiency (n = 0), cerebral hemorrhage (n = 0), pulmonary edema (n = 8), thromboembolism (n = 3), infection (n = 12), abruptio placentae (n = 5), encephalopathy (n = 4), post-op hemorrhage (n = 3), others (n = 10).
      In the group with PVE there were 25 complications in 19/111 patients and in the group without PVE there were 27 complications in 20/105 patients.

      Conclusion

      There were no statistically significant differences in maternal morbidity between treatment groups.