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Titre du document / Document title

Randomised controlled trial of ketanserin and aspirin in prevention of pre-eclampsia

Auteur(s) / Author(s)

STEYN D. W. ; ODENDAAL H. J. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

Department of Obstetrics and Gynaecology, Tygerberg Hospital and University of Stellenbosch, Tygerberg 7505, AFRIQUE DU SUD
Medical Research Council Unit for Perinatal Mortality, PO Box 19081, Tygerberg 7505, AFRIQUE DU SUD

Résumé / Abstract

Background Pre-eclampsia is associated with extensive endothelial-cell damage and platelet activation, resulting in lower production of vasodilator prostaglandins and increased release of the vasoconstrictors thromboxane A2 and serotonin. Damage to endothelial-cell serotonin-1 receptors leaves vasoconstriction and platelet aggregation mediated by serotonin-2 receptors unopposed. We investigated the role of ketanserin, a selective serotonin-2-receptor antagonist, in lowering the rate of pre-eclampsia among pregnant women with mild to moderate hypertension. Methods We recruited 138 pregnant women into a double-blind, randomised, placebo-controlled trial. They had diastolic blood pressure persistently more than 80 mm Hg before 20 weeks' gestation. 69 women received ketanserin and 69 received placebo. Both groups also received aspirin. Patients were initially given two tablets daily, increased to four tablets daily in diastolic blood pressure was more than 90 mm Hg. Primary outcomes were the development of pre-eclampsia and severe hypertension, and perinatal mortality. Findings There were significantly fewer cases of pre-eclampsia (two vs 13; relative risk 0.15 [95% CI 0.04-0.66], p=0.006) and severe hypertension (six vs 17; p=0.02) in the ketanserin than in the placebo group. There was also a trend towards less perinatal mortality (one vs six deaths) but this was not significant (p=0.28). Rates of abruptio placentae and pre-eclampsia before 34 weeks' gestation were lower in the ketanserin group, and mean birthweight was significantly higher. interpretation We found an association between the addition of ketanserin to aspirin and a decrease in the number of cases of pre-eclampsia and severe hypertension, as well as improved pregnancy outcome among patients with mild to moderate midtrimester hypertension.

Revue / Journal Title

Lancet    ISSN  0140-6736   CODEN LANCAO 

Source / Source

1997, vol. 350, no9087, pp. 1267-1271 (26 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, Kidlington, ROYAUME-UNI  (1823) (Revue)

Mots-clés anglais / English Keywords

Preeclampsia

;

Randomization

;

Controlled therapeutic trial

;

Ketanserin

;

Association

;

Double blind study

;

Acetylsalicylic acid

;

Pharmacokinetics

;

Prevention

;

Female

;

Human

;

Pregnancy disorders

;

Pregnancy toxemia

;

Serotonin antagonist

;

5-HT2 receptor

;

Antihypertensive agent

;

Vasodilator agent

;

Analgesic

;

Antipyretic

;

Non steroidal antiinflammatory agent

;

Salicylates

;

Mots-clés français / French Keywords

Prééclampsie

;

Randomisation

;

Essai thérapeutique contrôlé

;

Kétansérine

;

Association

;

Etude double insu

;

Acétylsalicylique acide

;

Pharmacocinétique

;

Prévention

;

Femelle

;

Homme

;

Gestation pathologie

;

Toxémie gravidique

;

Antagoniste sérotonine

;

Récepteur sérotoninergique 5-HT2

;

Antihypertenseur

;

Vasodilatateur

;

Analgésique

;

Antipyrétique

;

Antiinflammatoire non stéroïde

;

Salicylés

;

Mots-clés espagnols / Spanish Keywords

Preeclampsia

;

Aleatorización

;

Ensayo terapéutico controlado

;

Ketanserina

;

Asociación

;

Estudio doble ciego

;

Acetilsalicilico ácido

;

Farmacocinética

;

Prevención

;

Hembra

;

Hombre

;

Gestación patología

;

Toxemia gravídica

;

Antagonista serotonina

;

Receptor serotoninérgico 5-HT2

;

Antihipertensivo

;

Vasodilatador

;

Analgésico

;

Antipirético

;

Antiinflamatorio no esteroide

;

Salicilatos

;

Localisation / Location

INIST-CNRS, Cote INIST : 5004, 35400006863345.0070

Nº notice refdoc (ud4) : 2853956



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