A randomised double-blind placebo controlled trial of low molecular weight heparin as prophylaxis in preventing venous thrombolic events after caesarean section: a pilot study
A randomised double-blind placebo controlled trial of low molecular weight heparin as prophylaxis in preventing venous thrombolic events after caesarean section: a pilot study
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DOI：
10.1111/j.1471-0528.2001.00198.x
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发表时间：
2001-08-01
期刊：
影响因子：
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通讯作者：
Burrows, EA
中科院分区：
文献类型：
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作者：
Burrows, RF;Gan, ET;Burrows, EA
目的：为一项国家多中心随机试验试点方案，在该试验中，低分子量肝素将与安慰剂比较，以预防剖腹产后6周内发生的静脉血栓事件。设计双盲随机对照试验。三级护理中心设置。参与者76名剖宫产妇女，对照组37名，达尔特帕林组39名。方法同意急诊或择期剖宫产的患者术后6-24小时开始研究用药。研究药物达特帕林2500iu或生理盐水，根据患者的住院时间，每天皮下注射一次，持续4或5天。在医院复查患者的手术结果，并在术后2周和6周进行联系。结果在141名妇女中，76名（54%）同意参加试验。所有被招募的女性都随访了6周。安慰剂组有更多的妇女接受全身麻醉，但在随机分组中，两组具有相似的特征。在研究期间，只有一例深静脉血栓的发生。该患者在治疗组，血栓形成于术后2 - 6周。两组的所有其他结果相似。结论招募率为26%，血栓形成率为1.3% (95% CI 0.03-7.1%)，术后2周和6周所有参与者的可接触性表明本研究是可行的。
Objective To pilot a protocol for a national multicentre randomised trial in which a low molecular weight heparin will be compared with placebo for prevention of venous thrombotic events occurring within six weeks after caesarean section.Design Double-blind randomised controlled trial.Setting Tertiary care centre.Participants Seventy-six women having had a caesarean section, 37 in the control group and 39 in the Dalteparin group.Methods Consenting patients having had an emergency or elective caesarean section were commenced on study medication 6-24 hours post-operatively. The study medication, dalteparin 2500iu or saline, was oriven subcutaneously once daily for four or five days post-operatively depending on the patient's length of stay. Patients were reviewed in hospital for operative outcomes and contacted at two and six weeks post-operatively.Results Of the 141 women given information about the trial, 76 (54%) consented to participate. Follow up to six weeks was achieved in all women who were recruited. More women in the placebo arm had general anaesthesia, but otherwise the two groups had similar characteristics at randomisation. There was only one occurrence of a deep vein thrombosis during the study. This patient was in the treatment arm and the thrombosis occurred between two and six weeks post-operatively. All other outcomes were similar in the two groups.Conclusion Our experience of a 26% recruitment rate, the thrombosis rate of 1.3% (95% CI 0.03-7.1%) and the contactability of all participants two and six weeks post-operatively, indicates that this study is feasible.