| 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 |
1800 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 orally after cord clamp, followed by 2 doses 4 and 8 hours after delivery of 100 mcg misoprostol. Group 2: misoprostol 400 mcg orally 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.
226 (12.6%) exclusions after randomisation secondary to lack of haemoglobin measurements.
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 |
"computer‐based random allocation." |
| 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 |
226 (12.6%) exclusions after randomisation secondary to having caesarean sections and lack of haemoglobin measurements. |
| Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review have been reported. |
| Other bias |
Low risk |
The groups were comparable. |
