Agostini 2005.
| Methods | Single centre study. Described as randomised, but no details on how patients were allocated to trial interventions Patients, care providers, and outcome assessors were blinded to treatment allocation Power calculation performed No losses to follow up, and all patients were analysed in groups to which they were assigned Source of funding not mentioned | |
| Participants | Setting: university hospital in Marseille, France Inclusion criteria: patients with uterine myoma who required abdominal or vaginal myomectomy Exclusion criteria: preoperative embolisation and preoperative administration of any GnRh analogue n = 94 Mean age: 40 years (SD 5.2) in the treatment group and 39 years (SD 4.3) in the placebo group Ethnicity: not described Sizes of the fibroids: no significant difference in the weight and number of myomas between the treatment and control groups | |
| Interventions | Treatment arm (n = 47): 15 IU oxytocin administered by an IV infusion of 125cm3 of physiological serum over 30 min, beginning at the start of uterine incision
Control group (n = 47): physiological serum (placebo) administered in place of oxytocin Type of operation: laparotomy or vaginal route |
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| Outcomes | Perioperative blood loss, blood transfusion, and duration of surgery Blood loss was estimated using both the blood aspirated into the canisters, minus the irrigant, and the blood absorbed in the lap sponges | |
| Notes | Indications for myomectomy: bleeding, pelvic pain, and fertility Authors not contacted |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details on how patients were allocated to trial interventions |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
| Selective reporting (reporting bias) | Unclear risk | We do not have access to the study protocol |
| Other bias | Low risk | No other sources of bias identified |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both participants and care providers were blinded to treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded to treatment allocation |