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. 2015 Mar 20;2015(3):CD003988. doi: 10.1002/14651858.CD003988.pub2

Shaamash 2005.

Methods Time frame and location: conducted from June 2001 to June 2003 in Assiut, Egypt
Sample size calculation and outcomes of focus:
  • Breastfeeding rate: 151 per group for 80% power to detect difference of 15 per 100 women

  • Infant weight: 56 males and 56 females for 90% power to detect 400 gram difference at 12 months, assuming 20% attrition

Participants General with N and source: 320 exclusively breastfeeding women; university hospital clinic
Inclusion criteria: gave birth to healthy term baby with no health problem; had no contraindication to the use of LNG or copper IUD contraceptives; planning to breastfeed for at least 1 year
Exclusion criteria: not specified
Interventions Treatment: levonorgestrel‐releasing IUS (20 μg)
Comparison: Copper T 380A IUD
Timing: inserted 6 to 8 weeks postpartum
Outcomes Measures: breastfeeding (full, partial); infant growth (weight, length, head circumference, mid‐arm circumference, triceps skinfold); pregnancy (presumably self‐reported)
No sample sizes for analysis
Assessments: 3, 6, 9, 12 months postpartum
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization scheme was computer generated.
Allocation concealment (selection bias) Low risk Sealed opaque envelopes; opened in sequential order at time of enrollment
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information on losses or sample sizes for analysis