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. 2015 Jun 26;2015(6):CD003036. doi: 10.1002/14651858.CD003036.pub3

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
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
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"
Outcomes Expulsion rate, continuation rate, complication rate, removal rate for pain and bleeding, patient acceptability, failure rate
Assessment times: 6 months to 1 year
Notes Information from oral presentation (abstract only) and clinical trial listing
5 September 2014: Investigator communicated that final report was in progress
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