Frederick 1994.
Methods | Single centre study Randomisation by drawing numbers from a box. The numbers ranged from 1 to 20: when an odd number was drawn the patient received vasopressin, whereas an even number resulted in placebo being given Patients, care providers, and outcome assessors were blinded Power calculation: performed but study stopped half‐way and the code broken because of heavy bleeding in 10 patients 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, Kingston, Jamaica
Inclusion criteria: symptomatic uterine myoma at least size of 14 weeks gestation Exclusion criteria: contraindication to vasopressin (notably cardiovascular and respiratory diseases) n = 20 Median age: 32 years (range 24‐40) Ethnicity: not described Sizes of fibroids: 5.3‐14.0 cm |
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Interventions | Treatment (n = 10): injection into the broad ligaments of 20 units/ml of vasopressin (i.e. 1ml diluted in 19 ml saline) made up at the time of surgery Control: n = 10, Injection of placebo (20 ml normal saline) Type of operation: laparotomy | |
Outcomes | Perioperative blood loss, blood transfusion | |
Notes | Indications for myomectomy: menorrhagia, recurrent miscarriage, subfertility Authors not contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation by drawing numbers from a box |
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 | Participants and personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |