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. 2019 Apr 29;2019(4):CD001808. doi: 10.1002/14651858.CD001808.pub3

Abdel‐Aleem 2010.

Methods Randomised controlled trial.
Women were randomly allocated to 1 of 3 groups by selecting the next number in a computer‐generated random number sequence. The allocated group was noted inside opaque sealed envelopes. Not blinded.
Participants 1964 pregnant woman who were expected to have a vaginal delivery at Women's Health Center Assiut, Egypt and the Department of Obstetrics and Gynecology, East London Hospital Complex, East London South Africa between September 1, 2006 and February 28, 2009. Women were excluded for medical complications as follows; hypertension, diabetes, previous caesarean section, abdominal wall not thin enough to allow adequate palpation of uterus after delivery.
Interventions All interventions were given after delivery of the anterior shoulder or after delivery of the neonate.
1) 10 IU IM oxytocin (643 women)
2) Sustained uterine massage shortly after delivery performed by the research midwives; massage was sustained for 30 minutes an involved manual stimulation of the whole surface of the uterus (662 women)
3) Combined management with 10 IU IM oxytocin plus uterine massage (659 women)
In all 3 groups active management was performed: the umbilical cord was clamped soon after delivery of the neonate and the placenta was delivered by controlled cord traction when the uterus became contracted. A plastic drape or a low profile plastic bedpan was placed under the mother's buttocks after delivery of the neonate to collect the blood lost within 30 minutes of delivery. For the group that did not initially receive oxytocin, injections of oxytocin were given if blood loss > 500 mL occurred during the 30‐minute collection time.
Comparison for review is groups 1 and 3 combined (1302 women) vs group 2 (662 women)
Outcomes Blood loss > 300 mL, > 500 mL or > 1000 mL within 30 minutes of delivery, delivery of the placenta within 30 minutes of neonate delivery, use of additional uterotonics or other procedures to manage haemorrhage, Hb level after 12‐24 hours of < 8 g in 100 mL or < 10 g in 100 mL (South Africa only), blood transfusion, MRP or placenta not delivered in 30 minutes, maternal morbidity (including admission to higher level of care), and adverse effects (nausea, vomiting, pain or discomfort).
Notes Dates of study: September 2006‐February 2009
Funding sources: not reported
Declarations of interest: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Women were randomly allocated to 1 of 3 groups by selecting the next number in a computer‐generated random number sequence.
Allocation concealment (selection bias) Low risk The allocated group was noted inside opaque sealed envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No mention of blinding procedures, but given the nature of the treatments it would not have been possible to blind either participants or personnel
Assessment of blood loss leading to assessment of need for use of additional uterotonics can be subjective. Uterine massage too can vary amongst providers.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No mention of blinding procedures for outcome assessment. Some outcomes are subjectively assessed and lack of blinding could impact on outcomes, but others are objectively measured and lack of blinding would have little impact.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Minimal loss. Loss similar (n = 3 to 7) in each arm.
Selective reporting (reporting bias) Unclear risk All appear to be reported that are listed in methods text, however trial protocol not available.
Other bias Unclear risk Unclear.