Jangsten 2011

Methods	2‐arm controlled randomised trial.
Participants	Between November 2006 and April 2008, 1802 parturients were randomised in a hospital setting in Sweden. The population comprised women of parity 4 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing elective caesarean section, or those who were non‐Swedish speaking or with previous PPH, pre‐eclampsia, grand multiparity (more than 4) or intrauterine death.
Interventions	10 IU of oxytocin administered by an intravenous bolus (n = 903) versus of placebo or control (n = 899).
Outcomes	The study recorded the following outcomes: PPH at 1000, transfusion, manual removal of placenta, blood loss (mL), change in Hb level, third‐stage duration (min).
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)	Low risk	The randomisation was computer‐generated.
Allocation concealment (selection bias)	Low risk	Investigators used sealed envelopes containing the randomisation group prepared in consecutive order and kept in another unit. At randomisation, midwives phoned the staff at the other unit who opened the envelopes and disclosed the assigned intervention and trial number.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Because of the nature of the study, blinding was not possible for the midwives, but the parturients were not informed of which management was to be used for them."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessors were not blinded to treatment allocations.
Objective assessment of blood loss	Low risk	Investigators evaluated blood loss by removing pads soaked with amniotic fluid and placing a dry sanitary pad under the mother, immediately after the birth of the baby. They weighed all sanitary towels and pads before and after use. Blood loss was recorded (a) between the birth of the baby and the expulsion of the placenta, and (b) from expulsion of the placenta up to 2 hours postpartum.
Incomplete outcome data (attrition bias) All outcomes	Low risk	171 randomised women were not included in the study analysis. Among those randomised to receive oxytocin, 4 withdrew consent, 75 had caesareans, and 14 were lost to follow‐up. In the control group, 2 withdrew consent, 56 had caesareans, and 20 were lost to follow‐up.
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	High risk	The authors excluded 131 randomised study participants from the analysis because they experienced caesarean deliveries.
Funding source	Low risk	The study was supported by funding from the Research and Development Board in Göteborg and Bohuslän, Baby Bag and the SU Foundation in Sweden (public funding).