Ahuja 2014.
Methods | Location and time frame: New Delhi, India; planned time frame 16 January 2012 to mid‐2013 Design: randomized controlled trial Sample size calculation and outcome of focus: based on expulsion rate 11% in immediate group and 28% in early group, power 80% and 95% CI, attrition rate 25%; total calculated as 215 with 108 in each group |
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Participants | General with N: 263 women with vaginal delivery in 1 hospital Inclusion criteria: 15 to 45 years of age; willing to have postpartum CuT insertion and follow‐up until 6 months postpartum Exclusion criteria: contraindications to CuT 380A insertion; cesarean delivery |
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Interventions | CuT 380A IUD postplacental insertion Treatment: immediate (within 10 minutes of placenta expulsion); report refers to as "postplacental" Comparison: early (10 minutes to 48 hours post delivery); report refers to as "immediate postpartum" |
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Outcomes | Expulsion rate, continuation rate, complication rate, removal rate for pain and bleeding, patient acceptability, failure rate Assessment times: 6 months to 1 year |
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Notes | Information from oral presentation (abstract only) and clinical trial listing 5 September 2014: Investigator communicated that final report was in progress |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial listing states "not applicable" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up: not specified in abstract |