Carbonell 2009

Methods	2‐arm active‐controlled randomised trial.
Participants	Between April 2007 and October 2008, 1410 parturients were randomised in a hospital setting in Spain. The population comprised women of parity 4 or less, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing caesarean section or instrumental delivery, or those with gestational age less than 32 weeks, coagulopathy, Hb less than 80 g/L, liver or kidney disorder, grand multiparity (5 or more), hypersensitivity or any contraindication for use of prostaglandins.
Interventions	400 mcg and 200 mcg plus 10 IU of misoprostol plus oxytocin administered sublingually and rectally plus intramuscularly (n = 702) versus 10 IU of oxytocin administered intramuscularly (n = 698).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, morbidity, additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), change in Hb level, third‐stage duration (min), NNU admissions, nausea, vomiting, fever, shivering.
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	Random assignments were generated by computer.
Allocation concealment (selection bias)	Low risk	Investigators used sequentially‐numbered, opaque, sealed envelopes prepared by people not related to the study. This process was supervised by an analyst. Every morning a secretary received the sealed envelopes for distribution and this process was monitored by someone working on the study.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding (of study participants and caregivers) was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Assessor blinding was not reported.
Objective assessment of blood loss	Low risk	After delivery of the baby, investigators evaluated blood loss by collection with a sterile waterproof cloth placed under the mother, to channel blood into a bottle with capacity of 2 L: the volume reading was collected once beyond the third stage of labour.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"3 y 7 de las mujeres aleatorizadas a los grupos I y II, respectivamente, no recibieron ningún tratamiento por incumplimiento del protocolo y, como la información correspondiente a ellas no fue registrada en ningún momento, no forman parte de este informe": 3 women in the misoprostol plus active management group, and 7 women in the active management group, were excluded from the analysis due to protocol deviations and non‐availability of the information.
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	High risk	Those who withdrew from the study after randomisation were not included in the analysis.
Funding source	Low risk	The study was supported by the Science and Ethics Committee of the Hospital Eusebio Hernandez in Habana, Cuba in conjunction with the Clinica Mediterranea Medica in Valencia, Spain (the institutions of the authors).