Bullarbo 2005.
Methods | Randomised controlled trial. Figure 11. | |
Participants | Women (n = 24) failed to deliver the placenta 40 minutes after completion of second stage of labour despite additional administration of 10 IU oxytocin followed by controlled cord traction. All women were managed actively in the third stage of labour. Inclusion criteria: uncomplicated singleton pregnancy, spontaneous vertex delivery, healthy child. Exclusion criteria: pregnancy < 37 weeks, postpartum haemorrhage requiring immediate intervention, uterine malformation, intolerance to NTG, maternal age < 18 years, suspected placenta accreta, serious maternal disease. |
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Interventions |
Experimental Intervention: use of sublingual NTG tablets in a dose of 1 mg (2 tablets each is 0.5 mg) given 40 minutes after failure to deliver the placenta. Control intervention: 2 placebo tablets of similar design as the NTG tablets. Both groups received in addition oxytocin. |
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Outcomes |
Primary
Secondary
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated. |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Low risk for performance bias: the participating women were not aware of the agent administered. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk for detection bias: the obstetrician on duty was aware of the agent administered. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no loss to follow‐up. No excluded women. Analysis was by intention‐to‐treat. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes were reported in the results section. However, not all outcomes pre‐specified to be included in this review were reported in the trial. The study included the following outcomes; need for manual removal of placenta, haemodynamic changes of NTG (systolic blood pressure, diastolic blood pressure, pulse rate), mean blood loss during third stage of labour (although the method of estimation was not mentioned), side effects of NTG. |
Other bias | Low risk | There is no premature termination of the study, baseline imbalances or differential diagnosis. |