Wood 2002.
| Methods | Computer‐generated random number list in blocks. Pharmacy prepared numbered envelopes. Tablets not identical so placed by nurse in opaque vaginal introducer for physician to insert ‐ to maintain allocation concealment. Department of Obstetrics and Gynecology, University of Calgary, Calgary, Alberta, Canada; between February 1999 and April 2000. |
|
| Participants | 50 women with ultrasound diagnosed non‐viable pregnancies. Gestational age 7‐17 weeks but women not included if fetal size by ultrasound > 12 weeks equivalent. Also excluded from recruitment if experiencing uterine cramping or bleeding. | |
| Interventions | Misoprostol (800 mcg vaginally) (n = 25) or vaginal placebo (n = 25). If complete miscarriage not suspected after 24 hours, treatment was repeated. At 48 hours, if no miscarriage or miscarriage thought to be incomplete, uterine curettage was offered. | |
| Outcomes | Sample size based on reduction of uterine curettage from 50% to 10%. Women's satisfaction also assessed, but are not included in analyses as data not reported from control group. | |
| Funding | This work was supported by a grant from the Office of the Associate Dean of Research, Faculty of Medicine, University of Calgary. | |
| Declarations of interest | No information on conflicts of interest. | |
| Notes | Analysis by intention‐to‐treat. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: computer‐generated random number list in blocks. |
| Allocation concealment (selection bias) | Low risk | Comment: pharmacy prepared numbered envelopes. Tablets not identical so placed by nurse in opaque vaginal introducer for physician to insert ‐ to maintain allocation concealment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: it seems that all patients completed the study. Outcomes were presented for all patients. |
| Selective reporting (reporting bias) | Low risk | Comment: no signs of selective reporting. Outcome measures 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 | Low risk | Comment: tablets not identical so placed by nurse in opaque vaginal introducer for physician to insert ‐ to maintain allocation concealment. This assures blinding of patients and personnel. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: no information on blinding of outcome assessment. Considering that there was blinding of the physician treating the patient (by the use of a opaque vaginal introducer with either misoprostol or placebo) probably the physician was also blinded for outcome assessment. |
AP diameter: anterior‐posterior diameter bHCG: beta human chorionic gonadotrophin CRL: crown‐rump length ERPC: evacuation of retained products of conception hCG: human chorionic gonadotropin IM: intramuscular IU: international units IUFD: intrauterine fetal death mcg: microgram mm: millimetre MTX: methotrexate POC: products of conception RCT: randomised controlled trial TVS: transvaginal sonography vs: versus
µL: microlitre