Retrospective study of patients who were treated with fondaparinux pre-, peri- and/or postpartum for prophylaxis or treatment of venous thromboembolismFondaPPP
Trial overview
Number of participants receiving Fondaparinux in the indicated therapy intervals
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with the indicated reason for change to fondaparinux
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants administered the indicated dose of Fondaparinux per day
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration of Fondaparinux administration
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration of prenatal Fondaparinux administration
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration of postnatal Fondaparinux administration
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants for whom Fondaparinux administration was interrupted for birth
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of hours before birth that the Last Fondaparinux dose was administered
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of hours after birth at which Fondaparinux administration was restarted
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with the indicated reason for the end of Fondaparinux administration
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with the indicated outcome of pregnancy by type of birth
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with the indicated type of conception/fertilization
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants who delivered a single child versus twins
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Mean weight of newborn
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Mean height of newborn
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Mean head circumference of newborn
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Mean APGAR Score at 1, 5, and 10 minutes after birth
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of newborns who had a “healthy” postnatal classification
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of newborns with abnormalities
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants hospitalized because of thromboembolic treatment
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration of all hospitalizations under UFH, LMWH, and Fondaparinux administration
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration of hospitalizations before, during, and after Fondaparinux administration
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with complications under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with thromboembolisms under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with bleedings under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with skin changes under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration from start of UFH/LMWH therapy to skin change
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants who exhibited observed skin changes and also had erythema associated with the skin changes under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants who exhibited observed skin changes and also had skin necrosis associated with the skin changes under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with heparin-induced thrombocytopenia (HIT II) under UFH/LMWH therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration from start of UFH/LMWH therapy to HIT
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with and without complications under Fondaparinux therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with thromboembolisms under Fondaparinux therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with bleedings under Fondaparinux therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with skin changes under Fondaparinux therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Number of participants with heparin-induced thrombocytopenia (HIT II) under Fondaparinux therapy
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Duration from start of Fondaparinux therapy to HIT
Timeframe: 4 months (all cases occurred between 2004 and 2010)
Participation criteria
- Patients who were treated with fondaparinux pre-, peri- and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT)
- Patients who were treated with fondaparinux for less than 7 days
- Patient who were treated with fondaparinux only postpartum
- Patients who were treated with fondaparinux pre-, peri- and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT)
- Patients who were treated with fondaparinux for less than 7 days
- Patient who were treated with fondaparinux only postpartum
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.