Elk 1998.
Methods | RCT. | |
Participants | 12 cocaine‐dependent pregnant women: 58% African American, 8% Hispanic, 33% White; 92% never married or separated/widowed/divorced; 75% high school; 83% unemployed; 67% gravida 5 or more, 25% gravida 3 to 4; 75% in second trimester; DSM‐III‐R: 92% (10/11) cocaine primary drug of abuse, 8% (1/11) both heroin and cocaine dependent. Exclusion: Cessation of cocaine use greater than 30 days prior to enrolment. |
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Interventions | All received PNC, behaviourally‐based drug counselling, nutritional education, and HIV counselling.
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Outcomes | Retention in treatment as number remaining in treatment. Abstinence as average of individual %. Attendance in PNC as number of visits. Perinatal outcomes as number of preterm labour, or preterm delivery, or both. ASI composite scores presented as a bar graph. All outcomes reported as chi square with P value only when significant. | |
Notes | Treatment facility provided free transportation and child care. We attempted to contact trial authors but received no response. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Following stratification on referral source (self vs. court or probation or parole), subjects were randomly assigned to one of two treatment groups…" No details provided related to randomization methods. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition details outlined for the 12 women, all 12 carried throughout the analysis. Results have detailed participant numbers for each outcome. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No references to outcome assessor blinding made. |