Shaamash 2005.
Methods | Time frame and location: conducted from June 2001 to June 2003 in Assiut, Egypt Sample size calculation and outcomes of focus:
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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 |
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Interventions | Treatment: levonorgestrel‐releasing IUS (20 μg) Comparison: Copper T 380A IUD Timing: inserted 6 to 8 weeks postpartum |
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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 |
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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 |