Method for cohort and nested case-control studies: the prevalence, timing and effectiveness of obstetric ultrasound,...

The study was designed to assess the effectiveness of obstetric ultrasound in the diagnosis of congenital malformations and to establish its prevalence of use and timing. Statewide data were collected in 138 of the 141 obstetric hospitals in Victoria over a 12-month period during 1991-1992. Within the final cohort of 55,226 mothers providing responses, a nested case-control study group was formed. This group comprised 719 cases (infants born with one or more malformations potentially diagnosable at 16-20 weeks) and 703 controls (non-malformed infants). The cases for the group were extracted from the Victorian Congenital Malformations Register; controls were randomly selected from the Victorian Perinatal Data Collection Unit's database. Of the 1422 in the study group, 1328 medical records were validated in 100 hospitals. The design, method, procedure, sample and outcome are described for the cohort and nested case-control studies. At the conclusion of the study it was established that major variations between the cohort and missing data were confined to mothers less likely to have had a spontaneous vaginal delivery or to those with poor perinatal outcome. There was no significant selective loss of cases or controls in the nested case-control study group.