Welti 1981.
Study characteristics | ||
Methods | RCT | |
Participants | 580 women were randomised Setting: not clear, authors from Switzerland. Study dates: not reported. Inclusion criteria: women undergoing surgery for gynaecological indications (with 580 women undergoing caesarean section (both emergency and elective)). |
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Interventions |
Group 1 (n = 272): physiotherapy and twice‐daily subcutaneous 5000 IU heparin (UFH). Group 2 (n = 308): physiotherapy alone (no heparin). |
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Outcomes |
Review outcomes reported: symptomatic thromboembolic events; symptomatic PE; symptomatic DVT; bleeding episodes. Other outcomes: unclear (not translated) |
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Notes | Data extraction from translation notes and tables in the paper (original paper in French). Limited description of interventionand other (non review) outcomes. No information on timing of the intervention. 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 stated. |
Allocation concealment (selection bias) | Unclear risk | The study was conducted quote: "selon le principle de la randomisation fermee". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unlikely considering the interventions assessed. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear ‐ no detail of blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It appeared that all women were followed up. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol to confidently assess selective reporting. |
Other bias | Unclear risk | Insufficient information to assess other potential sources of bias. |
Abbreviations: APH: antepartum haemorrhage; APTT: activated partial thromboplastin time; BMI: body mass index; BP: blood pressure; DVT: deep vein thrombosis; FRUIT: Fractionated heparin in pregnant women with a history of uteroplacental insufficiency and thrombophilia (randomised trial); HELLP: Hemolysis, Elevated Liver enzyme levels, and low platelet levels; GA: gestational age; GI: gastrointestinal; Hb: haemoglobin; HES: hydroxyethyl starch; IgG: immunoglobulin g; IgM: immunoglobulin M; IU: international units; IUGR: intrauterine growth retardation; LMWH: low molecular weight heparin; NICU: neonatal intensive care unit; PAI: plasminogen activator inhibitor; PE: pulmonary embolism; RCT: randomised controlled trial; SGA: small‐for‐gestational age; tPA: tissue plasminogen activator (abbreviate; UFH: unfractionated heparin; VTE: venous thromboembolism; vWF: von Willebrand factor