Tang 2014.
Methods | Location: Raleigh, North Carolina (USA) Recruitment time: May 2011 to January 2012 Sample size calculation and outcome of focus: Assumed 20% LARC use in control, based on state survey results. Analysis population of 626 (313 in each arm) required for 80% power using two‐side alpha .05 to detect 10% increase to 30% LARC use in intervention arm. Assuming 20% drop‐out rate, 800 planned. |
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Participants | General with N: 800 healthy postpartum women Source: WakeMed Hospital Inclusion criteria:
Exclusion criteria:
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Interventions | 1) Intervention: routine postpartum counseling plus one‐minute script (LARC script), given to women during postpartum admission. Script informs about long‐acting reversible contraceptive (LARC) methods, i.e., contraceptive implant and IUD 2) Control: routine postpartum counseling (no LARC script and no standard counseling) |
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Outcomes | Primary: self‐reported LARC use Secondary: self‐reported interest in LARC use; use of any contraceptive method; reasons for not using contraceptive method of choice Assessment by 10‐min phone survey (25 items) after 6‐week postpartum visit |
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Notes | Due to error in preparing allocation envelopes, 394 allocated to LARC script (15 incorrectly) and 403 to no LARC script (19 incorrectly). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple 1:1 randomization scheme by computer generated blocks of 6, 8 and 10; developed and stored by statistician at North Carolina Translational and Clinical Sciences Institute |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque, sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blind (investigator and outcomes assessor); research assistants who opened allocation envelope were not same as those who completed participant follow‐up survey. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: intervention 31/400 (8%); control 31/400 (8%) |