Fugo 1958.
Methods | Randomised controlled trial. Numbered identical drug packages administered in rotation. Number meaningless to obstetrician. Blinded. |
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Participants | Women delivering in a hospital in Chicago, USA. No details given of inclusion/exclusion criteria, but description of study participants showed that half had labour over 8 hours, and 98% received some anaesthetic agent. |
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Interventions | All administered intravenously in 2 mL with anterior shoulder.
(1) 2 IU oxytocin (natural oxytocin) n = 168.
(2) 2 IU syntocinon (synthetic oxytocin) n = 156.
(3) 4 mg ergonovine 149.
(4) 80 mg U3772 (alpha, alpha diphenyl gamma dimethylamino N‐methyl valeramide‐HCl) n = 151.
Blood lost when the placenta separated was collected in a basin containing 200 mL of 4% sodium oxalate solution as an anticoagulant and was measured in a graduated jug. Expectant management of the third stage with MRP at 10 minutes for teaching purposes. Comparison for review is groups 1 and 2 combined vs group 3. |
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Outcomes | Method of placental delivery (high % of manual removals for teaching purposes if haemorrhage or undelivered within 10 minutes); length of third stage (not significantly different between groups but data only given for those delivered spontaneously, i.e. within 10 minutes); blood loss with placenta; (1‐hour postpartum average blood loss 50.2 vs 40.8 mL; no SDs given). | |
Notes | Given the high number of manual placental removals for teaching purposes, the data from this trial were not used due to concern for methodologic bias and lack of clinical translatability of this trial as MRP this early in the third stage is not standard of care. Dates of study: during 1958 Funding sources: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical packages were used, identifiable only by number, which was meaningless to the obstetrician in charge of the case. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Identical packages were used, identifiable only by number, which was meaningless to the obstetrician in charge of the case. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No significant attrition. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Unclear risk | Unclear. |