Heikkilä 1982.
Methods | Time frame and location: no time frame; conducted in Helsinki, Finland Some methods from secondary article Sample size calculation and outcome of focus: not specified |
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Participants | General with N and source: 80 women, delivered at State Maternity Hospital Inclusion criteria: breastfeeding and amenorrheic Exclusion criteria: not specified |
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Interventions | Treatment: levonorgestrel‐releasing IUD (30 μg) Comparison: Nova T intrauterine device (IUD) (copper releasing) Timing: inserted 6 weeks postpartum; range 29 to 56 days in one report, and 32 to 56 days in another |
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Outcomes | Measures: breastfeeding duration (no sample sizes for analysis); infant growth measured outside of study and presented in figure without actual numbers Assessment: unclear source and time frame; 75 days after insertion for analysis of breastfeeding data; secondary report notes recording of bleeding and spotting on cards and clinic visits at 3, 6, 12 months |
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Notes | Third group was added later (not randomized); received levonorgestrel‐releasing IUD (10 μg) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Divided at random" into 2 groups |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants did not know which IUD they received (30 μg/day LNG‐IUD or Nova T). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up: none
Discontinuation (expulsion or removal): 4 LNG‐IUD 30 μg; 4 Nova T. Also, 2 excluded from study due to uterine perforation at insertion (group not specified). Sample sizes for analysis not specified or inconsistent across reports. |