Ghazizadeh 2014.
Study characteristics | ||
Methods | Parallel randomised controlled trial | |
Participants | Department of Obstetrics and Gynecology and Maternal‐Fetal and Neonatal Research Center and Breastfeeding Research Center, Tehran University of Medical Sciences Inclusion criteria
Exclusion criteria
Setting: Tehran, Iran Time frame: October 2009 to November 2010 |
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Interventions | Bipolar endometrial ablation (Novasure) (n = 30) Hysteroscopic endometrial resection (HER) (n = 32) Mirena (lg‐IUS) (n = 48) |
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Outcomes | Decreased menstrual blood loss Interaction between bleeding and normal activity Anaemia (estimated 6.8 mg/dL as cut‐off for anaemia) Patients’ satisfaction (checklist 6 months' follow‐up; some up to 12) |
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Notes | Funding: not specified; includes the statement "No competing financial interest" Outcomes do not match correctly on the report. Study authors contacted for more details, no response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The title says RCT, but no data provided on the randomisation process |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label, lack of blinding likely to influence outcome. |
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin All outcomes | Low risk | Not blinded, lack of blinding unlikely to influence the outcome. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified, lack of blinding likely to influence outcome. |
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin) All outcomes | Unclear risk | Not blinded, lack of blinding unlikely to influence the outcome. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers in tables do not match numbers in text; study authors have been contacted for confirmation |
Selective reporting (reporting bias) | High risk | No quantification of bleeding; not specified at what time satisfaction was measured |
Other bias | High risk | Past medical history was positive in 12% Mirena, 13.3% Novasure, and 53.1% of HER (P < 0.0001) Ultrasonography was performed in 35.4% of patients in the Mirena group, 66.7% in the Nova‐Sure group, and 96.8% in the hysteroscopic endometrial resection group (P < 0.0001) |