Cg. Victora et al., THE LATIN-AMERICAN MULTICENTER TRIAL ON PSYCHOSOCIAL SUPPORT DURING PREGNANCY - METHODOLOGY AND BASE-LINE COMPARABILITY, Controlled clinical trials, 15(5), 1994, pp. 379-394
This article presents the methodology and baseline findings of a large
multicenter trial involving four countries from Latin America (Argent
ina, Brazil, Cuba, and Mexico). The study was a randomized, controlled
, single-masked trial to investigate the impact of social support duri
ng pregnancy on perinatal outcomes. Pregnant women with gestational ag
es between 15 and 22 weeks were screened in health facilities in the f
our countries. Those presenting with one or more risk factors for havi
ng a low-birthweight baby were invited to join the trial. A total of 2
235 women-between 500 and 600 in each country-were randomized into an
intervention (n = 1110) or a control (n = 1125) group. Both groups wer
e comparable in terms of nearly all baseline variables. The interventi
on group received a minimum of four visits at home by a trained health
worker who provided direct emotional support, health education, and a
n attempt to enhance the woman's social support network. Over 90% of a
ll women were evaluated at 36 weeks of pregnancy and soon after delive
ry, and 85% at the 40th day postpartum. The outcomes under study inclu
ded intrauterine growth retardation, gestational age, perinatal and ma
ternal morbidity and mortality, labor interventions, psychological dis
tress and characteristics of the social support network, among others.
This trial showed that it was possible to select, screen, randomize,
visit, and evaluate a large number of women in four Latin American cou
ntries using a standardized methodology.