Gilliam 2004.
Methods | Single site, parallel group RCT Location: Hospital in Chicago, IL, USA Time frame: 1998 to 1999 Sample size estimation and outcome of focus: not mentioned until discussion; sample size not sufficient to detect 20% difference between groups, due to resource limitations |
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Participants | General with N: 33 African American low‐income females attending Prentice Ambulatory Care; resident‐run clinic served low‐income women receiving public assistance Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention:
Comparison:
All participants received 3 labelled pill packets with instructions and telephone numbers for 24‐hour access if they had questions. |
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Outcomes | Continuation rate, switch to other contraceptives; pregnancy for 9 women (from delivery records or self‐report) Follow‐up: 1 year |
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Notes | Knowledge of OCs mentioned, but data reported elsewhere 43 women enrolled in Chicago study but only 33 randomized. Reasons for enrolment without randomization included participants changing their mind about using OCs, delivering at an outside hospital, and failure of study team to randomize participant prior to leaving hospital due to miscommunication with nursing staff or leaving after 24‐hour rather than 48‐hour stay. Trial registration: not stated Funding: Trial supported by a grant from the American College of Obstetricians and Gynecologists and Park‐Davis Research Award in Contraception Declarations of interest: no details provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table; randomized following delivery |
Allocation concealment (selection bias) | Low risk | Study packets were in envelopes that "concealed the contents" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Research team members reportedly blinded to group participation. No details provided of blinding of intervention providers; not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: 52% dropped out by 1 year; data on OC use for 76% (25/33) and on OC knowledge for 42% (14/33) Pregnancy data for 9 who dropped out from records or contacting participants; data loss 8/33 = 24% |
Selective reporting (reporting bias) | Unclear risk | No protocol was available, however, all outcomes prespecified in the manuscript were reported. |
Other bias | Unclear risk | Did not report any objective outcome measures |