Zimbabwe 2001.
Methods | Random allocation sequence generated by computer, allocation by numbered, sealed, opaque envelopes. Placebos used but were not identical. It is not mentioned whether outcome assessments were blinded or not. | |
Participants | 500 low‐risk women delivering at Harare Maternity Hospital, Zimbabwe were included. Women with a history of postpartum haemorrhage, disseminated intravascular coagulation, antepartum haemorrhage, coagulation disorders, operative delivery, multiple pregnancy, history of asthma and known allergies to misoprostol or oxytocin were excluded. | |
Interventions | Misoprostol 400 mcg orally + 1 mL saline (placebo) vs oxytocin 10 IU IM + 2 placebo tablets. | |
Outcomes | Blood loss, side‐effects. Measurement of blood loss: blood volume in jug + weighing of soiled linen. | |
Notes | Management of the third stage not described. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation sequence generated by computer. |
Allocation concealment (selection bias) | Low risk | Numbered, sealed, opaque envelopes. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear if the blinding was protected throughout the study or if the outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusions after randomisation: 1 women excluded because of undiagnosed twin delivery. |
Selective reporting (reporting bias) | Low risk | Primary outcomes of the review were reported. |
Other bias | Low risk | The groups were comparable. |
* (15(S) 15 methyl PGF2alpha) ** Synthetic PGE2 derivative (16‐phenoxy‐17,18,19,20‐tetranor‐PGE2‐methylsulphonamide) ANM: auxiliary nurse midwives BP: blood pressure GI: gastrointestinal Hb: haemoglobin Hct: haematocrit ICU: intensive care unit IM: intramuscular(ly) IU: international unit(s) IUGR: intrauterine growth restriction IV: intravenous(ly) MBL: measured blood loss PCV: packed cell volume PPH: postpartum haemorrhage vs: versus wks: weeks