| Methods |
Design: four group parallel trial
Purpose: examine the effect of prostaglandin E2‐alpha on cervical dilatation |
| Participants |
Patients: in‐patients undergoing first trimester abortion
Baseline comparability: yes |
| Interventions |
Placebo: intra‐cervically placed gel without prostaglandin
Untreated: no gel or tablet
Experimental:
‐intra‐cervically placed gel with prostaglandin E2‐alpha
‐tablet with prostaglandin E2‐alpha
(Co‐intervention: Valium on fixed scheme and analgesic on demand, distribution NS) |
| Outcomes |
Successful cervical dilatation (number of patients with dilatation of cervical os > Hegar no. 6) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Low risk |
'The investigating doctor had no idea what treatment, if any, the patients had received' |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 262 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
