Ngoc 2004.
Methods | Randomised by opening sequentially numbered envelope ‐ prepared by computer‐generated code in blocks of 10. Recruitment took place at Hung Vuong Hospital in Ho Chi Minh City, Vietnam, from January through August 2003. |
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Participants | 200 women in Ho Chi Minh City, Vietnam, with non‐viable first trimester pregnancies (anembryonic or early fetal death) diagnosed by ultrasound; cervix closed. | |
Interventions | Oral misoprostol 800 mcg (n = 100) vs vaginal misoprostol 800 mcg (n = 98). Women reviewed after 48 hours; if retained products present, they were given option of surgical evacuation or further review after another 5 days (when evacuation was performed if there were still products present). | |
Outcomes | Primary: complete miscarriage without need for surgical evacuation. Secondary: adverse effects. | |
Funding | Funding by David and Lucile Packard Foundation | |
Declarations of interest | No information on conflicts of interest. | |
Notes | 2 women lost to follow‐up. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: the randomisation scheme was created by Population Council staff, using a computer‐generated code in blocks of 10. |
Allocation concealment (selection bias) | Low risk | Quote: "The study investigator opened the next sequentially numbered randomized envelope to determine the treatment arm". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Two women in the vaginal group and one in the oral group were lost to follow‐up. One woman in the vaginal group was later reached by telephone". Comment: table 2 shows side effects for 190 patients (not 200 patients), so there are some missing data. This was < 10% of total study population. |
Selective reporting (reporting bias) | High risk | Comment: in table 2 side effects were presented for 95 patients per treatment arm, which is a sign of missing data. Analyses for these side effects were measured as an percentage of 95 women instead of 100 women. This influences the outcomes. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Neither the investigator nor the woman was blinded to the treatment assignment". Comment: due to the nature of the interventions (oral vs vaginal medication) blinding would have been difficult. Nonetheless this might have influenced (perception of) outcome. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no blinding of outcome assessment. |