| Methods |
Multicenter study. Randomisation by computer‐generated labels. Concealment of allocation by sealed opaque envelopes. Not stated whether sequentially numbered |
| Participants |
663 women requesting sterilisation to limit family size and free of major systemic and pelvic abnormalities. Interval (55%) and postspontaneous abortion (45%). Conducted in San Jose, San Salvador and Cairo |
| Interventions |
Tubal ring versus Rocket clip via minilaparotomy. Under general anaesthesia (55%) or local anaesthesia and intravenous sedation |
| Outcomes |
Major and minor morbidity, technical failures and difficulties, failure rates and complaints |
| Notes |
Blinding of postoperative evaluation. About 90% of women in both groups remained hospitalised for at least 1 night. The operations were performed with general anaesthesia in 55% of cases and with analgesia and/or sedation plus local anaesthesia in 45% of procedures |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation by computer‐generated labels |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment of allocation by sealed opaque envelopes. Not stated if sequentially numbered. Assessed as a 'B' study (unclear allocation concealment) in original review |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of postoperative evaluation |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
30 cases of technical failure (5% of total) were excluded from the analyses |
| Selective reporting (reporting bias) |
Unclear risk |
‐ |
| Other bias |
Unclear risk |
‐ |
