| Primary | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| | | Title | Denominators | Categories |
|---|
| Prenatal only | | | | Perinatal only | | | | Postnatal only | | |
| |
| Primary | Number of Participants With the Indicated Reason for Change to Fondaparinux | It was possible for a participant to have changed to fondaparinux for multiple reasons. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Duration of Fondaparinux Administration | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=101 participants with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Duration of Prenatal Fondaparinux Administration | The prenatal interval is defined as the interval of time until 3 days before birth. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=99 participants with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Duration of Postnatal Fondaparinux Administration | The postnatal interval is defined as the interval of time beginning 2 days after birth. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=90 participants with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=45 participants with non-missing data. | Posted | | Mean | Standard Deviation | hours | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Hours After Birth at Which Fondaparinux Administration Was Restarted | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=86 participants with non-missing data. | Posted | | Mean | Standard Deviation | hours | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | It is possible that a participant stopped receiving Fondaparinux for multiple reasons. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Participants With the Indicated Type of Conception/Fertilization | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Number of Participants Who Delivered a Single Child Versus Twins | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Primary | Mean Weight of Newborn | | Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=63 newborns with non-missing data. | Posted | | Mean | Standard Deviation | grams | | 4 months (all cases occurred between 2004 and 2010) | newborns | Participants | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum. |
| |
| Primary | Mean Height of Newborn | | Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=37 newborns with non-missing data. | Posted | | Mean | Standard Deviation | centimeters | | 4 months (all cases occurred between 2004 and 2010) | newborns | Participants | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum. |
| |
| Primary | Mean Head Circumference of Newborn | | Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=27 newborns with non-missing data. | Posted | | Mean | Standard Deviation | centimeters | | 4 months (all cases occurred between 2004 and 2010) | newborns | Participants | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum. |
| |
| Primary | Mean APGAR Score at 1, 5, and 10 Minutes After Birth | APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant. | Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=26 (1 min) or n=27 (5 and 10 min) newborns with non-missing data. | Posted | | Mean | Standard Deviation | scores on a scale | | 4 months (all cases occurred between 2004 and 2010) | newborns | Participants | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum. |
| |
| Primary | Number of Newborns Who Had a "Healthy" Postnatal Classification | A "healthy" documentation was based on the investigators' individual assessment. | Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. | Posted | | Number | | newborns | | 4 months (all cases occurred between 2004 and 2010) | newborns | Participants | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum. |
| |
| Primary | Number of Newborns With Abnormalities | No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment. | Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | newborns | | 4 months (all cases occurred between 2004 and 2010) | newborns | Participants | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum. |
| |
| Secondary | Number of Participants Hospitalized Because of Thromboembolic Treatment | Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=9 participants with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Duration of Hospitalizations Before, During, and After Fondaparinux Administration | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=3 participants (before Fondaparinux), n=5 participants (during Fondaparinux), and n=1 participant (after Fondaparinux) with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Complications Under UFH/LMWH Therapy | A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator). | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Thromboembolisms Under UFH/LMWH Therapy | Any sign of thromboembolism as indicated by investigator was measured. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Bleedings Under UFH/LMWH Therapy | No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Skin Changes Under UFH/LMWH Therapy | No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Duration From Start of UFH/LMWH Therapy to Skin Change | No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=27 participants with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy | Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis. | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy | Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis. | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy | HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Duration From Start of UFH/LMWH Therapy to HIT | | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=8 participants with non-missing data. | Posted | | Median | Full Range | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With and Without Complications Under Fondaparinux Therapy | A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator). | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Thromboembolisms Under Fondaparinux Therapy | Any sign of thromboembolism as indicated by investigator was measured. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Bleedings Under Fondaparinux Therapy | No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Skin Changes Under Fondaparinux Therapy | No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy | The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010 | Posted | | Number | | participants | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |
| Secondary | Duration From Start of Fondaparinux Therapy to HIT | For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented. | Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only one participant developed HIT after receiving Fondaparinux; thus, rather than presenting median data, data are presented as the number of days from start of therapy to HIT. | Posted | | Number | | days | | 4 months (all cases occurred between 2004 and 2010) | | | | ID | Title | Description |
|---|
| OG000 | Fondaparinux | Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. |
| |