Verkuyl 1993.
| Methods | Allocation was by means of a random number table, with group allocation sequentially placed in opaque, consecutively numbered envelopes. Follow‐up evaluator was unaware of patients study group. | |
| Participants | 357 women presenting with incomplete miscarriage in a hospital in Zimbabwe. Exclusion criteria: gestational age greater than 18 weeks, evidence of septicemia, peritonitis, severe hypovolemia requiring hospitalization. | |
| Interventions | Treatment with manual vacuum aspiration using plastic cannulae of 8 mm or 10 mm, versus sharp metal curettage, both in the theatre. | |
| Outcomes | Need for re‐evacuation, pain severity, possible uterine perforation, sepsis, mean blood loss, blood loss >= 100 ml, mean duration of procedure, duration >= 4 minutes, post‐op hemoglobin level, post‐op hemoglobin level <= 10 g/dl, hemoglobin level difference, mean duration of bleeding post‐evacuation. | |
| Notes | 41 (22.9%) women in the suction curettage group, and 46 (25.8%) in the sharp curettage group were lost to follow up and were excluded from some of the analyses. No mention was made of prophylactic antibiotic use. All patients received IV pethidine and diazepam. Ergometrine was also given routinely. Patients were followed up on post‐evacuation day 14. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Reported as "random number table". |
| Allocation concealment? | Low risk | Reported as using "opaque, consecutively numbered envelopes". |
| Blinding? All outcomes | Low risk | Participants were not blinded but "the follow‐up evaluator was unaware of the patient's study group". |
| Incomplete outcome data addressed? All outcomes | Low risk | "In the suction curettage group 138 (77%) patients attended for follow up compared with 132 (74%) in the conventional group." |
| Free of selective reporting? | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified. |
| Free of other bias? | Low risk | |
IV = intravenous g/dl = grams per decilitre ml = millilitre mm =millimetre