Methods |
Random allocation schedule generated by computer. Allocation made by opening sealed opaque envelopes which contained the names of the groups. No mention of consecutive numbering and opening. The obstetrician, surgical assistant, scrub nurse and recovery midwives were blinded to the group while anaesthetist was not. Double, non‐identical placebos were used. |
Participants |
40 women undergoing elective or emergency caesarean section in a university hospital in London, United Kingdom. Women with 2 or more caesarean sections or a history of previous ruptured uterus were excluded. Other eligibility criteria are not mentioned. |
Interventions |
Misoprostol 500 mcg orally + 2 mL IV normal saline bolus vs 10 IU oxytocin bolus + 2 placebo tablets. |
Outcomes |
Blood loss (clinical estimation), change in Hb levels, shivering (assessed in the recovery room), temperature within 1 hour. |
Notes |
Management of third stage: 'active' during caesarean section. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"computer generated random numbers." |
Allocation concealment (selection bias) |
Unclear risk |
Allocation made by opening sealed opaque envelopes which contained the names of the groups. No mention of consecutive numbering and opening. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
The obstetrician, surgical assistant, scrub nurse and recovery midwives were blinded to the group while anaesthetist was not. Double, non‐identical placebos were used. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No withdrawals after caesarean section. |
Selective reporting (reporting bias) |
Unclear risk |
Not all of the primary outcomes of the review were reported. |
Other bias |
Low risk |
The groups were comparable. |