Kalogiannidis 2011.
| Methods | Randomised controlled trial with 30 participants assigned to group I (misoprostol group) and 34 participants assigned to group II (placebo group) Prospective randomised trial performed among women scheduled from February 2007 and February 2009 Setting: Hospital in Greece Power calculation performed No loss to follow up |
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| Participants | Inclusion criteria: menstruating women aged ≤ 45 years, with three or less myomas of diameter ranging between 30mm and 90mm. Patients with cervical or endometrial pathology as well as with adnexal masses were excluded Intervention group: mean age of 37.2 years (SD = 6.5) and control group: mean age of 34.8 years (SD = 4.6) Ethnicity not reported Intervention group: n = 30 Control group: n = 34 |
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| Interventions | Intervention group received 400mg intravaginal misoprostol 1hr before surgery and the control group received intravaginal placebo 1hr before surgery. The intravaginal placebo was ‘similar’ to the misoprostol. All patients had laparoscopic myomectomy | |
| Outcomes | Outcomes measured included postoperative Hb, postoperative anaemia, blood transfusion, duration of the operation, side‐effects, and blood loss. Blood loss was estimated as the difference between the irrigated and aspirated liquid from the peritoneal cavity during the operation (no gauze was used) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants described as ‘randomly’ allocated to the intervention and control groups, but no details given |
| Allocation concealment (selection bias) | Low risk | Allocation concealment was achieved using sequentially numbered opaque sealed envelopes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete data reported |
| 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 health personnel were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |