Dahlgren 2007.
Study characteristics | ||
Methods | RCT | |
Participants | 55 women presenting for elective CS Inclusion criteria: healthy women with term singleton normal pregnancies Setting: Sweden |
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Interventions |
Colloid versus crystalloid preload Group 1: colloid group: 20 mL of 15% dextran 1, followed by 1000 mL IV infusion of 3% dextran 60. This solution was administered during 20 min immediately preceding intrathecal injection. Group 2: crystalloid group: 20 mL IV injection of 0.9% saline, followed by 1000 mL IV infusion of acetated Ringer's solution. This solution was administered during 20 min immediately preceding intrathecal injection. All women received standardised fasting protocol, no premedication and a standardised spinal anaesthetic technique and dose. Hypotension requiring intervention was managed with ephedrine 5 mg if SBP dropped below 100 mmHg, and repeated as required. |
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Outcomes |
Maternal: hypotension – overall, clinically significant or severe Criteria for rescue: if the woman developed discomfort associated with a decrease in SBP of at least 20% from baseline, even if it was above 100 mmHg |
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Notes | 'Overall' hypotension defined as a fall in systolic pressure below 100 mmHg 'Clinically significant' hypotension defined as hypotension associated with maternal discomfort (nausea, retching/vomiting, dizziness or chest symptoms) 'Severe' hypotension defined as a reduction of the SAP below 80 mmHg |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly allocated" – method not specified |
Allocation concealment (selection bias) | Unclear risk | Sealed envelope |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | 'Double‐blind'. The woman, the anaesthesiologist and all other personnel in the operating room were unaware of the study group. The study solutions were prepared and administered by an anaesthetic nurse who was not otherwise involved in the care of the patient, and were covered by a non‐transparent plastic bag. The anaesthesiologist did not enter the operating room until the study solution had been given. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All personnel were blinded to treatment allocation, except for the anaesthetic nurse who prepared the solutions (who was not involved in the care of the patient). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2/55 excluded due to protocol violation (1 was given ephedrine despite a normal BP and the other could not go through the SST because of leg muscle spasm). Not specified which groups they were from |
Selective reporting (reporting bias) | Low risk | Only maternal outcome reported was hypotension; no infant outcomes were reported |
Other bias | Low risk | No apparent sources of other bias |