| Methods |
Randomisation based on computer‐generated random numbers. Sealed, consecutively‐numbered, opaque envelopes were used. Identical placebos were used except for the misoprostol tablets which were similar in size and colour but not in shape. There was blinding of outcome assessments. Midwives administered the misoprostol tablets, but residents that were blinded to the intervention, did the outcome assessments. |
| Participants |
1633 women with vaginal births in Ankara, Turkey. Exclusion criteria: Gestational age < 32 weeks, caesarean delivery, hypersensitivity to prostaglandins. |
| Interventions |
Women randomised into 4 groups, all received corresponding placebos.
Group 1: oxytocin 10 IU IV plus misoprostol 400 mcg rectally after cord clamp, followed by 2 doses 4 and 8 hours after delivery of 100 mcg misoprostol. Group 2: misoprostol 400 mcg rectally after cord clamp followed by 2 doses 4 hours apart of 100 mcg misoprostol. Group 3: oxytocin 10 IU IV.
Group 4: oxytocin 10 IU IV plus 1 mL methylergometrine IM. |
| Outcomes |
Blood loss, transfusion, change in Hb, need for additional uterotonics, length of the third stage, subsequent evacuation of uterus, frequency of delayed haemorrhage, side‐effects. Clinical estimation of blood loss was done. |
| Notes |
Active management of third stage with early cord clamping, traction, and uterine massage.
Concurrent study at this institution with similar design but evaluating oral misoprostol also published and is included in this meta‐analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"table of computer generated blocks of random numbers." |
| Allocation concealment (selection bias) |
Low risk |
"sealed, consecutively numbered opaque envelopes." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Identical placebos were used except for the misoprostol tablets which were similar in size and colour but not in shape. There was blinding of outcome assessments. Midwives administered the misoprostol tablets, but residents that were blinded to the intervention, did the outcome assessments. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
27 exclusions after randomisation secondary to lack of Hb measurements. These were spread out among the 4 groups. |
| Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review have been reported. |
| Other bias |
Low risk |
There were no significant differences among the groups. |
