Cornette 2002.
Study characteristics | ||
Methods | RCT | |
Participants | 44 women were randomised. Setting: authors from Belgium (no further details provided). Study dates: not reported. Inclusion criteria: women with full‐term singleton pregnancies admitted for elective caesarean section. Exclusion criteria: women with known bleeding or coagulation disorders. |
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Interventions |
Group 1 (n = 22): preoperative, 0.3 mL nadroparin calcium (LMWH), administered 12 hours before elective caesarean birth. Group 2 (n = 22): postoperative, 0.3 mL (2850 IU) nadroparin calcium, administered 12 hours after elective caesarean birth. All women received the same fluid regimen before, during and after surgery. Women were allowed to drink freely 6 hours after surgery. It was not clear whether participants received any further doses of LMWH after initial dose. |
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Outcomes |
Review outcomes reported: none. Other outcomes reported: Hb and haematocrit concentrations 12 hours before and 48 hours after surgery (as a substitute for blood loss). |
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Notes | No outcomes included in the review analysis as outcomes were not relevant to the review. The power calculation was based on changes in Hb levels. 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 | Not described, quote: "randomly divided in two groups". |
Allocation concealment (selection bias) | Unclear risk | As above. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible due to nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No detail of blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up apparent. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol to confidently assess selective reporting; furthermore, no relevant outcome data were reported. |
Other bias | Low risk | No other obvious risk of bias identified. |