THE LATIN-AMERICAN MULTICENTER TRIAL ON PSYCHOSOCIAL SUPPORT DURING PREGNANCY - METHODOLOGY AND BASE-LINE COMPARABILITY

Citation
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
Citations number
14
Categorie Soggetti
Medicine, Research & Experimental
Journal title
ISSN journal
01972456
Volume
15
Issue
5
Year of publication
1994
Pages
379 - 394
Database
ISI
SICI code
0197-2456(1994)15:5<379:TLMTOP>2.0.ZU;2-D
Abstract
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.