Trinder 2006.
Methods | Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage. This was a multi‐centre trial with 7 participating hospitals, each of which had an early pregnancy clinic. Recruitment started in May 1997 and finished in December 2001. | |
Participants | Women with a pregnancy of less than 13 weeks’ gestation who had been diagnosed as having either an incomplete miscarriage or early fetal/embryonic demise were eligible. | |
Interventions | Intervention: in the medical management arm, women with an incomplete miscarriage were admitted to hospital and given a single vaginal dose of 800 mcg misoprostol.1200 women with early fetal or embryonic demise were pre‐treated with a single oral dose of 200 mg mifepristone,21 then admitted to hospital 24‐48 hours later for a single vaginal dose of 800 mcg misoprostol (n = 398). Control: women in the expectant management arm were allowed home with no intervention (n = 399). Control: women in the surgical management arm were admitted for surgical suction curettage under general anaesthesia (n = 403). |
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Outcomes | Confirmed gynaecological infection at 14 days and 8 weeks; need for unplanned admission or surgical intervention. | |
Funding | The MIST study was funded by a South and West NHS Executive research and development grant. A donation of £20 000 was accepted from Exelgyn. Neither the NHS Executive nor Exelgyn had any role in the study design; collection, analysis, or interpretation of data; writing of the report; or the decision to submit the paper for publication. | |
Declarations of interest | The study group accepted a donation of £20 000 from Exelgyn, the manufacturers of mifepristone. The authors have no other competing interests. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomisation was by a central telephone system at the Clinical Trials Services Unit, Oxford. We used minimisation to ensure comparability between women with respect to participating centre, parity, type of miscarriage, and gestation". Comment: this still does not state how the randomisation scheme was generated. |
Allocation concealment (selection bias) | Low risk | Comment: use of a central telephone system for randomisation, operated by other persons than the doctors randomising the patients. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: according to the flowchart loss to follow‐up was < 10%. |
Selective reporting (reporting bias) | Low risk | Comment: flow chart displays all eligible and recruited women. No signs of selective reporting; all outcomes mentioned in the methods section were presented in the results section. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: there is no information on blinding of patients and personnel. However, due to the nature of the interventions, blinding would be practically impossible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessment, probably not done. |