The safe passage study: design, methods, recruitment, and follow-up approach.
Paediatr Perinat Epidemiol
; 28(5): 455-65, 2014 Sep.
Article
em En
| MEDLINE
| ID: mdl-25131605
ABSTRACT
BACKGROUND:
The Safe Passage Study is a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders.METHODS:
The results provided are based on an interim assessment of 6004 women enrolled, out of the 12,000 projected, from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research objectives, study design, and descriptive statistics, including consent, recruitment, and retention information, are provided.RESULTS:
Overall visit compliance is 87%, and includes prenatal, delivery/newborn, and postnatal contacts through 1 year post-delivery. Pregnancy outcome ascertainment is 98% prior to medical chart review; less than 2% of women withdraw. Consent for the use of DNA and placental tissue exceed 94%, and consent to participate in the autopsy portion of the study is 71%.CONCLUSIONS:
The Safe Passage Study is the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/infant dyad using a common protocol. Essential components of the study design and its success are close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Morte Súbita do Lactente
/
Consumo de Bebidas Alcoólicas
/
Natimorto
/
Transtornos do Espectro Alcoólico Fetal
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
/
Infant
/
Pregnancy
País/Região como assunto:
Africa
/
America do norte
Idioma:
En
Revista:
Paediatr Perinat Epidemiol
Assunto da revista:
EPIDEMIOLOGIA
/
PEDIATRIA
/
PERINATOLOGIA
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Marrocos