Jain 1996*.
Methods | "Random number table". From the Department of Obstetrics and Gynecology, University of Southern California School of Medicine; no information on study duration. |
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Participants | 70 women in Los Angeles, USA, with either fetal death (n = 40) or medical or genetic indications for termination of pregnancy (n = 30) at 12‐22 weeks. Only data from pregnancies complicated by fetal death included here. | |
Interventions | Vaginal misoprostol 200 mcg 12‐hourly plus laminaria tents (n = 20) vs vaginal misoprostol 200 mcg 12‐hourly alone (n = 18). | |
Outcomes | Miscarriage. | |
Funding | No information on funding. | |
Declarations of interest | No information on conflicts of interest. | |
Notes | Adverse effects are described for the groups as wholes, so are not included here. 2 women excluded from analyses ‐ 1 protocol violation; 1 was found to have interstitial ectopic pregnancy. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: use of a random number table. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome was described for all 38 patients. 2 patients were excluded before analyses (1 protocol violation and 1 found to have interstitial ectopic pregnancy). |
Selective reporting (reporting bias) | Low risk | Comment: no signs of selective reporting. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no information on blinding of patients and personnel. Due to the nature of the intervention (misoprostol with or without laminaria tents) it is unlikely that there was blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: there is no information on blinding of outcome assessment. Considering the type of treatment (laminaria tents or not) it is unlikely that there was blinding. |