Methods |
2‐arm active‐controlled randomised trial. |
Participants |
Between the beginning of August 2007 and the end of December 2007, 100 parturients were randomised in a hospital setting in Iran. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised parturients with multiple pregnancy, prolonged labour more than 12 h, 2 or more previous caesarean sections, previous uterine rupture, Hb less than 80 g/L, who had a history of heart, renal or liver disorders or had a coagulopathy. |
Interventions |
400 mcg of misoprostol administered sublingually (n = 50) versus 20 IU of oxytocin administered by an intravenous infusion (n = 50). |
Outcomes |
The study recorded the following outcomes: additional uterotonics, blood loss (mL), change in Hb level. |
Notes |
Contact with study authors for additional information: yes. Additional data from authors: no. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
By a simple randomisation method, patients were allocated into 2 equal groups. |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
Study participants and caregivers were not blinded to treatment allocations. |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
Low risk |
Investigators evaluated blood loss by collection in a suction bottle, and with drapes and pads beneath the mother. Amniotic fluid was suctioned and measured, and then subtracted from the total volume of the suction bottle. Meanwhile the known dry weight(s) of drapes and pads were subtracted from the soaked weights of these materials. Measurements of blood collected in the suction bottle and on drapes and pads were added together. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
Selective reporting (reporting bias) |
High risk |
The protocol of the study was unavailable for verification, but not all of the outcomes projected by methodological descriptions were reported as results in the study report (cases of transfusion were omitted). |
Intention to treat analysis |
Unclear risk |
The authors did not specify whether all those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised. |
Funding source |
Unclear risk |
Source(s) of funding for the study were not reported. |