Methods |
Computer‐generated, random‐number schedule with a random block list. Random allocation by giving the next of a series of non‐distinguishable envelopes containing active or placebo tablets. Identical placebos were used. Outcome assessments were blinded. |
Participants |
1620 women delivering at home or primary care centre in 4 primary health centre areas of Belgaum District, Karnataka State, India. Women were delivered by ANMs who were trained in the trial procedures and the intervention. 2 sets of midwives were involved in the study. 18 at the beginning and 12 leaving and replaced by 7 new ANMs. |
Interventions |
Misoprostol 600 mcg orally vs identical placebos. |
Outcomes |
Blood loss, side‐effects.
Blood loss measurement: A calibrated blood collection drape placed under the buttocks following delivery. Blood loss was measured after 1 hour and 2 hours. |
Notes |
Management of the third stage: the ANMs practised expectant management of the third stage of labour apart from the uterotonic in the intervention arm. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"computer generation randomization list with a random block size." |
Allocation concealment (selection bias) |
Low risk |
"non‐distinguishable envelopes." |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, placebo‐controlled. Outcome assessments were blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No mention of loss to follow‐up or exclusion after randomisation. |
Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review were reported. |
Other bias |
Low risk |
"The two groups did not differ across any characteristics." |