A randomised controlled trial comparing two temporising management strategies, one with and one without plasma volume expansion, for severe and early onset pre-eclampsia

Objectives Plasma volume expansion may benefit both mother and child in the temporising management of severe and early onset hypertensive disorders of pregnancy. Design Randomised clinical trial. Setting Two university hospitals in Amsterdam, The Netherlands. Population Two hundred and sixteen patients with a gestational age between 24 and 34 completed weeks with severe pre-eclampsia, haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome or severe fetal growth restriction (FGR) with pregnancy-induced hypertension, admitted between 1 April 2000 and 31 May 2003. Methods One hundred and eleven patients were randomly allocated to the treatment group, (plasma volume expansion and a diastolic BP target of 85-95 mmHg) and 105 to the control group (intravenous fluid restriction and BP target of 95-105 mmHg). Main outcome measures Neonatal neurological development at term age (Prechtl score), perinatal death, neonatal morbidity and maternal morbidity. Results Baseline characteristics were comparable between groups. The median gestational age was 30 weeks. In the treatment group, patients received higher amounts of intravenous fluids (median 813 mL/day vs 14 mL/day; P < 0.001) with a concomitant decreased haemoglobin count (median -0.6 vs-0.2 mmol/L; P < 0.001). Neither neurological scores nor composite neonatal morbidity differed. A trend towards less prolongation of pregnancy (median 7.4 vs 11.5 days; P= 0.054) and more infants requiring oxygen treatment > 21% (66 vs 46; P= 0.09) in the treatment group was observed. There was no difference in major maternal morbidity (total 11%), but there were more caesarean sections in the treatment group (98%vs 90%; P < 0.05). Conclusion The addition of plasma volume expansion in temporising treatment does not improve maternal or fetal outcome in women with early preterm hypertensive complications of pregnancy.