The Barbados low-dose aspirin in pregnancy (BLASP): a population based trial in a developing country with excess pre eclampsia and perinatal mortality
West Indian med. j
; West Indian med. j;45(Supl. 2): 26, Apr. 1996.
Article
em En
| MedCarib
| ID: med-4624
Biblioteca responsável:
JM3.1
Localização: JM3.1; R18.W4
ABSTRACT
A large randomised controlled double blind trial (RCT), BLASP was set up in Barbados' one main maternity centre (QEH). Almost all women at 12-32 weeks attending for antenatal booking were eligible in the period July 1992-1994. After consent, entry details were recorded on a computer with random allocation to either a slow-release 75 mg aspirin (A) or a placebo (P). Intention-to-treat analysis, based on the 3,643 randomized pregnant women (1,819 allocated aspirin and 1,824 a placebo), is viewed in context of all other randomised control trials (RCTs). Entry date balanced in A and P for gestational age of 20.2 weeks, average maternal age 24 years, more than half aged 20-29 years and 44 percent primigravidae. Previous obstetric complications were lower than expected at 5 percent. Family histories of diabetes mellitus and hypertension were high (> 33 percent). Compliance was moderate with 36 percent taking allocated tablets for more than 95 percent of the time, but a third for less than 80 percent. There were no serious side effects, and in particular no bleeding. PE rates were low at 2.2 percent in A and 2.5 percent in P, a 13.3 percent odds reduction with wide 95 percent CI showing no significant effect. A tendency in all predefined categories (PE + PIH, etc.) for fewer cases in A (n=203, 11.2 percent) than in P (n=231, 12.7 percent) is not confirmed in an overview of all trials. Antenatal hospital admissions occurred in 34 percent of A and 33 percent of P. There was no difference in very low-birth-weight (<1500 g) but rates were 7 percent in A and 8.3 percent in P for birthweight between 1,500 and 2,499 g. Mean pregnancy duration was virtually identical at 38.7 (SD 3.6) weeks. Stillbirths and neonatal death rates were 2.3 percent and 2 percent, and Caesarean Sections 13.6 and 13.8 percent, in A and P, respectively. It is concluded that in this large RCT conducted in the Caribbean (BLASP), there were no meaningful differences between those allocated aspirin or placebo but event rates were low, perhaps due to the "healthier recruit" effect. In the context of all other published randomised trials, these results confirm that aspirin has little effect on the prevention of PE or PIH or other specified outcomes but is entirely safe (AU)
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Coleções:
01-internacional
Base de dados:
MedCarib
Assunto principal:
Aspirina
/
Eclampsia
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Female
/
Humans
/
Pregnancy
País/Região como assunto:
Barbados
/
Caribe ingles
Idioma:
En
Revista:
West Indian med. j
Ano de publicação:
1996
Tipo de documento:
Article
/
Congress and conference