Shokeir 2013.
| Methods | Randomised controlled trial with 54 participants assigned to receive a single dose of intravaginal 20mg dinoprostone and 54 participants received a placebo Setting: Mansoura University Hospital in Egypt Power calculation performed |
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| Participants | Women with uterine leiomyomas. Exclusion criteria were any contraindication to dinoprostone, a known history of pelvic/ovarian endometriosis, a known history or active medical disease, a known history of previous myomectomy, women who had preoperative mifepristone, GnRH analogue or oral contraceptive pills, women with mental impairment or incompetent in giving consent and women who did not wish to participate in the study Ethnicity not reported |
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| Interventions | The intervention group received 20mg dinoprostone (prostaglandin E2 analogue, medications that arrest bleeding by causing contraction of muscles of the uterus) vaginal suppository before the operation. The control group received intravaginal placebo tablet of the same size and shape as dinoprostone. All patients had open abdominal myomectomy | |
| Outcomes | The primary outcome was blood loss and the secondary outcome measures were blood transfusion, change in Hb level, and incidence of side effects. Blood loss was estimated by measuring the amount of blood accumulated in the aspiration equipment and the amount of blood on the surgical gauze using alkaline hematin technique | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were assigned serial numbers and were allocated through a stratified randomisation according to the surgeons. Random sequence was generated by computer in blocks of four |
| Allocation concealment (selection bias) | Low risk | Group assignment was put into sealed, opaque envelopes. After recruitment the envelope was opened by the research nurse not involved in the project |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no incomplete data; No loss of follow up |
| 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 | Participants and the personnel were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |