Dal'Ava 2014.
| Methods | Design: prospective matched Location: single site in Campinas, Brazil Time frame: enrolled October 2009 to June 2011 Sample size estimation and outcome of focus: reported change in baseline percentage of body fat 12 months after initiation of contraception (primary outcome), 1.75% increase in DMPA users vs 0.31% reduction in Cu IUC users; required 20 complete cases in each group, using repeated measures ANOVA with 5% significance level and 80% power |
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| Participants | 97 women Inclusion criteria: 18 to 50 years of age; new DMPA or Cu IUC users Exclusion criteria: breastfeeding; use of DMPA in prior 6 months; history of diabetes, pituitary disorder, liver or kidney disease, cancer; use of corticosteroids, diuretics, hormone therapy; eating disorder |
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| Interventions | 1) DMPA 150 mg (N = 55) 2) Cu T380A IUC (N = 42) |
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| Outcomes | Change in weight (kg), fat mass (kg), and lean mass (kg) Follow‐up: 12 months |
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| Notes | Women using Cu IUC may overlap with those in Dal'Ava 2012; study periods overlap and inclusion criteria are similar. Unable to obtain further information from investigator. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Participants chose method |
| NOS selection (NRS) | Low risk | Exposed: volunteered for study; unclear if they were clinic attendees Non‐exposed: same population as exposed but chose different contraceptive method Exposure: clinic records (inserted IUC and administered DMPA) |
| NOS comparability (NRS) | Low risk | Design: paired by age (± 2 years) and weight (± 2 kg) for intervention groups Analysis: control variables of physical activity, consumption of coffee and alcohol, smoking in regression; reportedly not significant |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to women having chosen contraceptive method |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention; objective outcome measure |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up and discontinuation: DMPA 53% (29/55); IUC 24% (10/42) From IUC group, only 26 of 32 matched with 26 in DMPA group Major differential losses between groups |