Kushwah 2009.
Methods | Parallel group randomised controlled trial. Patients were randomly assigned to 1 of 2 groups by computer‐generated numbers. The study was conducted from April 2003 to March 2004 with 100 women attending the prenatal clinic of the Department of Obstetrics and Gynecology of Sucheta Kriplani Hospital, Delhi, India. All had early pregnancy failure confirmed by ultrasound between the 7th and 14th week. | |
Participants | The inclusion criteria were (1) a gestational sac of 25 mm in mean diameter or larger with no embryo present (an anembryonic pregnancy) or (2) the presence of a fetal pole without cardiac pulsations (a missed abortion). |
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Interventions | Group 1: 200 mg mifepristone + 600 mcg misoprostol sublingually; with up to 3 supplemental doses of 400 mcg after 12, 15 and 18 hours (if 4 hours after last dose still no expulsion: surgical evacuation) (n = 50). Group 2: 200 mg mifepristone + 600 mcg misoprostol orally; with up to 3 supplemental doses of 400 mcg after 12, 15 and 18 hours (if 4 hours after last dose still no expulsion: surgical evacuation) (n = 50). |
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Outcomes | The primary outcome was the mean induction‐to‐evacuation interval, defined as the time between when the first dose of misoprostol was taken and the time when the POC were expelled. The secondary outcome was the incidence of the 5 following adverse effects: blood loss, abdominal pain, nausea, vomiting, diarrhoea, and fever. Regimen acceptability was defined as whether it would be accepted again, if needed. | |
Funding | No information on funding. | |
Declarations of interest | No information on conflicts of interest. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were then randomly assigned to one of 2 groups by computer generated numbers". |
Allocation concealment (selection bias) | Unclear risk | Comment: no adequate description of the concealment process |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: for all 100 patients outcomes were presented. |
Selective reporting (reporting bias) | Low risk | Comment: outcome measures that were 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: due to the nature of the intervention blinding would be difficult; the only way for blinding both participants and personnel would be to give group A oral misoprostol and sublingual placebo and group B oral placebo and sublingual misoprostol. The article does not state that placebos were used. This might particularly have influenced patients experiences that were assessed as secondary outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessment, probably not done. |