WHO 1983.
Methods | Design: phase III randomized controlled trial Location: 13 centers in Africa, Asia, Central and South America, and Europe Time frame: recruitment began 1977; final follow‐up March 1982 Sample size estimation and outcome of focus: no information |
|
Participants | 3172 women; mean age 27.4 years Inclusion criteria: non‐breastfeeding women who chose injectable contraception Exclusion criteria: contraindication for long‐acting contraceptive methods |
|
Interventions | 1) DMPA 150 mg at 90‐day intervals (N = 1587) 2) Norethisterone enanthate (NET‐EN) 200 mg at 60‐day intervals (N = 789) 3) NET‐EN 200 mg at 60‐day intervals for 6 months then 84‐day intervals (N = 796) | |
Outcomes | Mean weight change by contraceptive group Follow‐up: 12 and 24 months |
|
Notes | Method for measuring weight not mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated" |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to differences in injection schedules for interventions |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: reportedly 10.7% DMPA; 8.9% NET‐EN 60 days; 9.8% NET‐EN 84 days Life‐table rates for total discontinuation: 71% to 74% |
BMI: body mass index DMPA: depot medroxyprogesterone acetate FSH: follicle stimulating hormone LNG‐IUC: levonorgestrel‐releasing intrauterine contraception MPA: medroxyprogesterone acetate NET‐EN: norethisterone enanthate NRS: non‐randomized study OC: oral contraceptive SD: standard deviation