Methods |
Design: three group parallel trial
Purpose: examine the effect of bromocriptine on breast pain and milk secretion after abortion |
Participants |
Patients: women having undergone a second‐trimester abortion
Baseline comparability: yes |
Interventions |
Placebo: a tablet without bromocriptine
Untreated: no tablet
Experimental: a tablet containing bromocriptine
(Co‐intervention: no) |
Outcomes |
Breast pain (VAS) and serum prolactin (micro g/l)
Breast tenderness
Milk secretion |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
NS |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
Low risk |
'The part of the study that involved bromocriptine and placebo was carried out 'double‐blind'' |
Blinding?
Outcome assessor |
Unclear risk |
NS |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop out > 15 % or NS |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
Trial size > 49? |
High risk |
N = 34 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |