BJOG : an international journal of obstetrics and gynaecology · 2005
A randomised controlled trial comparing two temporising management strategies, one with and one without plasma volume expansion, for severe and early onset pre-eclampsia.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Ganzevoort Wessel, Rep Annelies, Bonsel Gouke J, Fetter Willem P F, van Sonderen Loekie, De Vries Johanna I P, Wolf Hans, PETRA investigators
Аннотация
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.
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.