OBJECTIVE: The purpose of this study was to conduct pilot studies for large randomized controlled trials to compare low-molecular-weight heparin with placebo for antenatal thromboprophylaxis (trial 1), and for thromboprophylaxis after cesarean delivery (trial 2). STUDY DESIGN: Multicenter randomized controlled trials (trial 1, 23 units; trial 2, 8 units) were conducted. Pregnant women at increased risk for thromboembolic disease were eligible for trial 1; women who underwent cesarean delivery were eligible for trial 2. The interventions were once daily injections of low-molecular-weight heparin or placebo. Primary outcomes were as follows: trial 1, confirmed symptomatic thromboembolic events and symptomatic osteoporotic fractures; trial 2, confirmed symptomatic thromboembolic events and wound complications. RESULTS:Sixteen women were recruited for trial 1; 1 woman in theplacebo group had a symptomatic thromboembolic event. One hundred forty-one women were recruited for trial 2; 1 woman in the low molecular weight heparin group had a symptomatic thromboembolic event. CONCLUSION: Poor recruitment indicates that large-scale trials using these designs would be difficult. Collection of data on the number of women that are eligible and the reasons for nonrecruitment in future trials of these interventions would allow a better understanding of the reasons for poor recruitment.
RCT Entities:
OBJECTIVE: The purpose of this study was to conduct pilot studies for large randomized controlled trials to compare low-molecular-weight heparin with placebo for antenatal thromboprophylaxis (trial 1), and for thromboprophylaxis after cesarean delivery (trial 2). STUDY DESIGN: Multicenter randomized controlled trials (trial 1, 23 units; trial 2, 8 units) were conducted. Pregnant women at increased risk for thromboembolic disease were eligible for trial 1; women who underwent cesarean delivery were eligible for trial 2. The interventions were once daily injections of low-molecular-weight heparin or placebo. Primary outcomes were as follows: trial 1, confirmed symptomatic thromboembolic events and symptomatic osteoporotic fractures; trial 2, confirmed symptomatic thromboembolic events and wound complications. RESULTS: Sixteen women were recruited for trial 1; 1 woman in the placebo group had a symptomatic thromboembolic event. One hundred forty-one women were recruited for trial 2; 1 woman in the low molecular weight heparin group had a symptomatic thromboembolic event. CONCLUSION: Poor recruitment indicates that large-scale trials using these designs would be difficult. Collection of data on the number of women that are eligible and the reasons for nonrecruitment in future trials of these interventions would allow a better understanding of the reasons for poor recruitment.
Authors: Shannon M Bates; Ian A Greer; Saskia Middeldorp; David L Veenstra; Anne-Marie Prabulos; Per Olav Vandvik Journal: Chest Date: 2012-02 Impact factor: 9.410
Authors: Mark H Eckman; Pablo Alonso-Coello; Gordon H Guyatt; Shanil Ebrahim; Kari A O Tikkinen; Luciane Cruz Lopes; Ignacio Neumann; Sarah D McDonald; Yuqing Zhang; Qi Zhou; Elie A Akl; Ann Flem Jacobsen; Amparo Santamaría; Joyce Maria Annichino-Bizzacchi; Wael Bitar; Per Morten Sandset; Shannon M Bates Journal: Thromb Res Date: 2015-05-22 Impact factor: 3.944
Authors: Nancy L Shapiro; Michelle A Kominiarek; Edith A Nutescu; Aimee B Chevalier; Judith U Hibbard Journal: Pharmacotherapy Date: 2011-07 Impact factor: 4.705
Authors: Shannon M Bates; Anita Rajasekhar; Saskia Middeldorp; Claire McLintock; Marc A Rodger; Andra H James; Sara R Vazquez; Ian A Greer; John J Riva; Meha Bhatt; Nicole Schwab; Danielle Barrett; Andrea LaHaye; Bram Rochwerg Journal: Blood Adv Date: 2018-11-27
Authors: Pablo Alonso-Coello; Shanil Ebrahim; Gordon H Guyatt; Kari A O Tikkinen; Mark H Eckman; Ignacio Neumann; Sarah D McDonald; Elie A Akl; Shannon M Bates Journal: BMC Pregnancy Childbirth Date: 2012-05-30 Impact factor: 3.007