N/A
Completed N=120
Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism
Source: ClinicalTrials.gov NCT01004939 ↗Enrolled (actual)
120
Serious AEs
4.1%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals — 6; 0; 1; 3 participants
Summary
The objective of this retrospective study is to gather information about how fondaparinux is used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous thromboembolism (VTE) in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals |
6; 0; 1; 3; 1; 2 | — |
| PRIMARY Number of Participants With the Indicated Reason for Change to Fondaparinux |
12; 50; 3; 3; 0; 16 | — |
| PRIMARY Number of Participants Administered the Indicated Dose of Fondaparinux Per Day |
2; 94; 16; 1; 3; 4 | — |
| PRIMARY Duration of Fondaparinux Administration |
131 | — |
| PRIMARY Duration of Prenatal Fondaparinux Administration |
130 | — |
| PRIMARY Duration of Postnatal Fondaparinux Administration |
23 | — |
| PRIMARY Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth |
9; 20; 91 | — |
| PRIMARY Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered |
34.6 | — |
| PRIMARY Number of Hours After Birth at Which Fondaparinux Administration Was Restarted |
11.3 | — |
| PRIMARY Number of Participants With the Indicated Reason for the End of Fondaparinux Administration |
18; 94; 6; 0; 0; 5 | — |
| PRIMARY Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth |
11; 71; 3; 34; 1 | — |
| PRIMARY Number of Participants With the Indicated Type of Conception/Fertilization |
2; 107; 1; 10 | — |
| PRIMARY Number of Participants Who Delivered a Single Child Versus Twins |
116; 4 | — |
| PRIMARY Mean Weight of Newborn |
3042 | — |
| PRIMARY Mean Height of Newborn |
49.6 | — |
| PRIMARY Mean Head Circumference of Newborn |
34 | — |
| PRIMARY Mean APGAR Score at 1, 5, and 10 Minutes After Birth |
8.6; 9.1; 9.6 | — |
| PRIMARY Number of Newborns Who Had a "Healthy" Postnatal Classification |
10; 110; 4 | — |
| PRIMARY Number of Newborns With Abnormalities |
10; 114 | — |
| SECONDARY Number of Participants Hospitalized Because of Thromboembolic Treatment |
120; 102; 18 | — |
| SECONDARY Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration |
5 | — |
| SECONDARY Duration of Hospitalizations Before, During, and After Fondaparinux Administration |
10; 5; 2 | — |
| SECONDARY Number of Participants With Complications Under UFH/LMWH Therapy |
120; 40; 31; 49 | — |
| SECONDARY Number of Participants With Thromboembolisms Under UFH/LMWH Therapy |
120; 118; 2 | — |
| SECONDARY Number of Participants With Bleedings Under UFH/LMWH Therapy |
120; 118; 2 | — |
| SECONDARY Number of Participants With Skin Changes Under UFH/LMWH Therapy |
120; 80; 40 | — |
| SECONDARY Duration From Start of UFH/LMWH Therapy to Skin Change |
42 | — |
| SECONDARY Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy |
40; 4; 36 | — |
| SECONDARY Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy |
40; 32; 8 | — |
| SECONDARY Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy |
120; 111; 9 | — |
| SECONDARY Duration From Start of UFH/LMWH Therapy to HIT |
27.5 | — |
| SECONDARY Number of Participants With and Without Complications Under Fondaparinux Therapy |
120; 111; 9 | — |
| SECONDARY Number of Participants With Thromboembolisms Under Fondaparinux Therapy |
120; 120 | — |
| SECONDARY Number of Participants With Bleedings Under Fondaparinux Therapy |
120; 118; 2 | — |
| SECONDARY Number of Participants With Skin Changes Under Fondaparinux Therapy |
120; 120 | — |
| SECONDARY Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy |
120; 119; 1 | — |
| SECONDARY Duration From Start of Fondaparinux Therapy to HIT |
15 | — |
Eligibility Criteria
Inclusion 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)
Exclusion Criteria
- Patients who were treated with fondaparinux for less than 7 days
- Patient who were treated with fondaparinux only postpartum
Data sourced from ClinicalTrials.gov (NCT01004939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.