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. 2018 Apr 25;2018(4):CD011689. doi: 10.1002/14651858.CD011689.pub2
Methods 3‐arm active‐controlled randomised trial.
Participants Over 8 months between dates unspecified, 2023 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, 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 those with asthma, cardiac disorder, rhesus factor incompatibility or hypertension.
Interventions 400 mcg of misoprostol administered orally (n = 730) versus 10 IU of oxytocin administered intramuscularly (n = 617) versus 200 mcg of ergometrine administered by an intravenous bolus (n = 676).
Outcomes The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), change in Hb level, third‐stage duration (min), nausea, vomiting, headache, fever, shivering.
Notes Contact with study authors for additional information: yes. Additional data from authors: yes.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was achieved using computer‐generated random numbers.
Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported.
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 the drainage of amniotic fluid, investigators evaluated blood loss by collection with a large sterile plastic bag placed under the mother until she was transferred to the postnatal department. The blood collected in the plastic bag was then transferred to a measuring jar. Mops were not used in the labour room, and gauze pieces were counted.
Incomplete outcome data (attrition bias) All outcomes Unclear risk The study authors did not mention any incomplete outcome data.
Selective reporting (reporting bias) Unclear risk The protocol of the study was unavailable for verification.
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.

ACTRN, Australian Clinical Trials Registration Number; ANOVA, one‐way Analysis Of Variance; ASA I or II, ASA Physical Status Classification System: ASA I represents a normal healthy patient, ASA II represents a patient with mild systemic disease; BMI, Body Mass Index; cc, cubic centimetres; CHOs, community health officers; cm, centimetres; CTRI, Clinical Trials Registry of India; DIC, Disseminated Intravascular Coagulopathy; dL, decilitres; EudraCT, European Clinical Trials database; fL, femtolitres (measurement of mean corpuscular volume); g, grams; Hb, Haemoglobin; HELLP syndrome, Hemolysis (destruction of red blood cells), Elevated Liver enzymes (which indicate liver damage), and Low Platelet count; HIV, Human Immunodeficiency Virus; Hong Kong SAR, Hong Kong Special Adminstrative Region; IU, International Units; kg, kilograms; km, kilometres; L, litres; mcg, micrograms; mg, milligrams; min, minutes; mL, millilitres; mmHG, millimetres of mercury (unit of pressure); mmol, millimoles; NCT, National Clinical Trial (number); NEPU, National Perinatal Epidemiology Unit; NHS, National Health Service; nm, nanometres; NNU, Neonatal Unit; PACTR, Pan African Clinical Trials Registry; PPH, Postpartum Haemorrhage; PROM, Premature Rupture Of Membranes; RCOG, Royal College of Obstetricians and Gynaecologists; UK, United Kingdom; UNDP/UNFPA, United Nations Development Programme/United Nations Population Fund; USA, United States of America; WHO, World Health Organization.