Low-molecular-weight heparin and aspirin in the prevention of recurrent early-onset pre-eclampsia in women with antiphospholipid antibodies: the FRUIT-RCT

Autor: Dick Bezemer, Marielle G. van Pampus, Marion E. van Hoorn, William M. Hague, Johanna I.P. de Vries
Přispěvatelé: Obstetrics and gynaecology, Epidemiology and Data Science, MOVE Research Institute, ICaR - Ischemia and repair
Jazyk: angličtina
Rok vydání: 2016
Předmět:
030204 cardiovascular system & hematology
0302 clinical medicine
Recurrence
CLASSIFICATION CRITERIA
Netherlands
Randomised controlled trial
Aspirin
education.field_of_study
030219 obstetrics & reproductive medicine
Obstetrics and Gynecology
Antiphospholipid Syndrome
Intention to Treat Analysis
Treatment Outcome
PREGNANCY
Infant
Small for Gestational Age

Antibodies
Antiphospholipid

Premature Birth
Drug Therapy
Combination

Female
medicine.drug
Adult
medicine.medical_specialty
medicine.drug_class
HELLP syndrome
Population
INTERNATIONAL CONSENSUS STATEMENT
Low molecular weight heparin
Gestational Age
CONTROLLED-TRIAL
03 medical and health sciences
Young Adult
Fibrinolytic Agents
Antiphospholipid syndrome
Internal medicine
medicine
Humans
Low-molecular-weight heparin
education
Gynecology
Sweden
Pregnancy
Eclampsia
business.industry
Antiphospholipid antibodies
Australia
Infant
Newborn

WORKSHOP
Hypertension
Pregnancy-Induced

Heparin
Low-Molecular-Weight

medicine.disease
Pregnancy Trimester
First

Reproductive Medicine
UPDATE
business
Pre-eclampsia
Fibrinolytic agent
Zdroj: European Journal of Obstetrics and Gynecology and Reproductive Biology, 197, 168-173. Elsevier Ireland Ltd
van Hoorn, M E, Hague, W M, van Pampus, M G, Bezemer, D & de Vries, J I P 2016, ' Low-molecular-weight heparin and aspirin in the prevention of recurrent early-onset pre-eclampsia in women with antiphospholipid antibodies: the FRUIT-RCT ', European Journal of Obstetrics and Gynecology and Reproductive Biology, vol. 197, pp. 168-173 . https://doi.org/10.1016/j.ejogrb.2015.12.011
European journal of obstetrics gynecology and reproductive biology, 197, 168-173. ELSEVIER SCIENCE BV
ISSN: 0301-2115
Popis: To examine whether combined treatment with low-molecular-weight heparin (LMWH) and aspirin reduces recurrent hypertensive disorders of pregnancy (HD: pre-eclampsia, eclampsia or HELLP syndrome) in women with antiphospholipid antibodies (aPLA) and a previous delivery for HD and/or small-for-gestational-age (SGA) birthweight before 34 weeks gestation.This multicentre randomised controlled trial was performed between December 2000 and December 2009. Women were recruited from all eight university and six non-university/teaching hospitals in The Netherlands, two university hospitals in Australia and one university hospital in Sweden. Thirty two women with a previous delivery34 weeks gestation with HD and/or SGA and aPLA were included before 12 weeks gestation. The intervention was daily LMWH with aspirin or aspirin alone.recurrent HD onset34 weeks and recurrent HD irrespective of gestational age. Analysis by intention-to-treat.After an interim analysis, recruitment was ceased: accrual was low and the incidence of recurrent HD was far lower (3%) than expected (60%). The final analysis, performed on 32 women, shows no difference in the primary outcomes (LMWH and aspirin 0/16 versus aspirin only 1/16, risk difference 6.25% [CI -17 to 27%] for recurrent HD onset34 weeks and 0/16 for LMWH and aspirin versus 2/16 for aspirin only, risk difference 12.5% [CI -15 to 35%] for HD irrespective of gestational age).In this population of women with aPLA, who had previously had an early delivery for HD and/or SGA prior to 34 weeks gestation, combined LMWH and aspirin treatment started before 12 weeks gestation in a subsequent pregnancy did not show reduction of onset of recurrent HD either34 weeks gestation or irrespective of gestational age, compared with aspirin alone.
Databáze: OpenAIRE