Thromboembolism, Venous Thromboembolism
Conditions
Keywords
prophylaxis, venous thromboembolism, postpartum, fondaparinux, pregnancy
Brief 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.
Detailed description
During pregnancy there is a generally enhanced risk to develop venous thromboembolism (VTE). Although such events are rare they may lead to serious risks for the mothers´ and children´s health. Compared with non-pregnant women, pregnant women have an about five-fold risk to develop VTE. Due to their characteristic spectrum of side effects and the generally long duration of exposure in pregnancy the preferred anticoagulants may produce potentially dangerous side effects, as bleedings, heparin-induced thrombocytopenia (HIT), allergic reactions, osteoporosis, or congenital anomalies. Today, low-molecular weight heparins (LMWH) are the preferred agents for anticoagulation in pregnancy. Compared with unfractioned heparins (UFH) LMWHs have the advantages of a lower bleeding risk, a lower rate of allergic reactions and HIT, a more predictable response and a longer half-life that makes dosing more convenient (od or bid). Still, there is a considerable proportion of pregnancies where heparin intolerance (allergic reactions or HIT) that make it inevitable to change to another anticoagulant. On the one hand, fondaparinux has repeatedly been reported successful in the VTE prophylaxis of pregnancies where allergic reactions on heparins, or heparinoids, had occurred. Additionally, a considerable amount of oral reports have reached GSK about an additional number of successful cases in the past. On the other hand, we have no systematic and overall view about how many pregnancies have already been treated for which reasons, and how successful they were. Due to an increase of certain risk factors, as obesity or the growing age of mothers at childbirth with the associated need for anticoagulation, we expect an increased number of cases where alternative anticoagulation to heparins may be needed. There are a number of potential advantages of fondaparinux over heparins, such as a once daily application, no dose adjustment needed to body weight and no monitoring of thrombocytes, a lower potential for causing intolerance reactions and no risk for HIT. 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 VTE in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.
Interventions
DRUGfondaparinux
fondaparinux
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight of Newborn | 4 months (all cases occurred between 2004 and 2010) | — |
| Mean Height of Newborn | 4 months (all cases occurred between 2004 and 2010) | — |
| Mean Head Circumference of Newborn | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Participants With the Indicated Type of Conception/Fertilization | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Participants Who Delivered a Single Child Versus Twins | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | 4 months (all cases occurred between 2004 and 2010) | 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. |
| Number of Participants With the Indicated Reason for Change to Fondaparinux | 4 months (all cases occurred between 2004 and 2010) | It was possible for a participant to have changed to fondaparinux for multiple reasons. |
| Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | 4 months (all cases occurred between 2004 and 2010) | — |
| Duration of Fondaparinux Administration | 4 months (all cases occurred between 2004 and 2010) | — |
| Duration of Prenatal Fondaparinux Administration | 4 months (all cases occurred between 2004 and 2010) | The prenatal interval is defined as the interval of time until 3 days before birth. |
| Duration of Postnatal Fondaparinux Administration | 4 months (all cases occurred between 2004 and 2010) | The postnatal interval is defined as the interval of time beginning 2 days after birth. |
| Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Hours After Birth at Which Fondaparinux Administration Was Restarted | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | 4 months (all cases occurred between 2004 and 2010) | It is possible that a participant stopped receiving Fondaparinux for multiple reasons. |
| Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | 4 months (all cases occurred between 2004 and 2010) | — |
| Mean APGAR Score at 1, 5, and 10 Minutes After Birth | 4 months (all cases occurred between 2004 and 2010) | 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. |
| Number of Newborns Who Had a Healthy Postnatal Classification | 4 months (all cases occurred between 2004 and 2010) | A healthy documentation was based on the investigators' individual assessment. |
| Number of Newborns With Abnormalities | 4 months (all cases occurred between 2004 and 2010) | No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy | 4 months (all cases occurred between 2004 and 2010) | 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. |
| Duration From Start of Fondaparinux Therapy to HIT | 4 months (all cases occurred between 2004 and 2010) | For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented. |
| Number of Participants Hospitalized Because of Thromboembolic Treatment | 4 months (all cases occurred between 2004 and 2010) | Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism. |
| Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration | 4 months (all cases occurred between 2004 and 2010) | — |
| Duration of Hospitalizations Before, During, and After Fondaparinux Administration | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Participants With Complications Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator). |
| Number of Participants With Thromboembolisms Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | Any sign of thromboembolism as indicated by investigator was measured. |
| Number of Participants With Bleedings Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment. |
| Number of Participants With Skin Changes Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. |
| Duration From Start of UFH/LMWH Therapy to Skin Change | 4 months (all cases occurred between 2004 and 2010) | No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. |
| Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins. |
| Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins. |
| Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy | 4 months (all cases occurred between 2004 and 2010) | 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. |
| Duration From Start of UFH/LMWH Therapy to HIT | 4 months (all cases occurred between 2004 and 2010) | — |
| Number of Participants With and Without Complications Under Fondaparinux Therapy | 4 months (all cases occurred between 2004 and 2010) | A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator). |
| Number of Participants With Thromboembolisms Under Fondaparinux Therapy | 4 months (all cases occurred between 2004 and 2010) | Any sign of thromboembolism as indicated by investigator was measured. |
| Number of Participants With Bleedings Under Fondaparinux Therapy | 4 months (all cases occurred between 2004 and 2010) | No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment. |
| Number of Participants With Skin Changes Under Fondaparinux Therapy | 4 months (all cases occurred between 2004 and 2010) | No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fondaparinux Retrospective systematic documentation of female participants 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. | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Fondaparinux |
|---|---|
| Age Continuous | 31.5 Years STANDARD_DEVIATION 5.4 |
| Body Mass Index (BMI) | 26.5 kilograms (kg)/meters squared (m^2) STANDARD_DEVIATION 6.2 |
| Duration of LMWH administration | 54 days |
| Duration of UFH administration | 32 days |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Certoparin | 1 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Dalteparin | 35 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Enoxaparin | 28 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Missing | 45 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Nadroparin | 21 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Reviparin | 0 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Tinzaparin | 0 participants |
| Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) Total | 120 participants |
| Number of participants receiving the indicated type of prophylactic treatment Prophylaxis: internal medicine | 31 participants |
| Number of participants receiving the indicated type of prophylactic treatment Prophylaxis: surgery | 5 participants |
| Number of participants receiving the indicated type of prophylactic treatment Prophylaxis: thromboembolic risk | 99 participants |
| Number of participants receiving therapeutic treatment for the given indications Acute coronary syndrome | 0 participants |
| Number of participants receiving therapeutic treatment for the given indications Alternative anticoagulation at atrial fibrilation | 0 participants |
| Number of participants receiving therapeutic treatment for the given indications Alternative anticoagulation at heart valve | 1 participants |
| Number of participants receiving therapeutic treatment for the given indications Data missing | 1 participants |
| Number of participants receiving therapeutic treatment for the given indications Peripheral arterial disease | 0 participants |
| Number of participants receiving therapeutic treatment for the given indications Therapy: deep vein thrombosis | 7 participants |
| Number of participants receiving therapeutic treatment for the given indications Therapy: pulmonary embolism | 3 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications Acute VTE during pregnancy | 1 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications Antiphospholipid syndrome | 14 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications Antithrombine deficiency | 3 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications Long-time anticoagulation with oral anticoagulants | 4 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications Thrombophilia | 82 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications VTE in anamnesis | 33 participants |
| Number of participants receiving thromboembolic prophylaxis for the given indications Women with >=2 risk factors | 9 participants |
| Number of participants undergoing either prophylaxis or therapy Prophylaxis | 111 participants |
| Number of participants undergoing either prophylaxis or therapy Therapy | 11 participants |
| Number of participants who did and did not receive UFH Did not receive UFH | 117 participants |
| Number of participants who did and did not receive UFH Received UFH | 3 participants |
| Number of participants who indicated that they did or did not have former abortions Missing data | 2 participants |
| Number of participants who indicated that they did or did not have former abortions No | 51 participants |
| Number of participants who indicated that they did or did not have former abortions Total | 85 participants |
| Number of participants who indicated that they did or did not have former abortions Yes | 32 participants |
| Number of participants with known thrombophilia Antiphospholipid syndrome | 15 participants |
| Number of participants with known thrombophilia Antithrombin deficiency | 2 participants |
| Number of participants with known thrombophilia Factor VII activating protease (FSAP) | 6 participants |
| Number of participants with known thrombophilia Factor VII C46T | 18 participants |
| Number of participants with known thrombophilia Factor V Leiden mutation heterozygous | 13 participants |
| Number of participants with known thrombophilia Factor V Leiden mutation homozygous | 0 participants |
| Number of participants with known thrombophilia None | 20 participants |
| Number of participants with known thrombophilia Other | 46 participants |
| Number of participants with known thrombophilia Persistant factor VIII increase | 4 participants |
| Number of participants with known thrombophilia Protein C deficiency | 5 participants |
| Number of participants with known thrombophilia Protein S deficiency | 10 participants |
| Number of participants with known thrombophilia Prothombin mutation homozygous | 0 participants |
| Number of participants with known thrombophilia Prothrombin mutation heterozygous | 13 participants |
| Number of participants with the indicated anamnestic thromboembolisms Arterial only | 0 participants |
| Number of participants with the indicated anamnestic thromboembolisms Both arterial and venous | 2 participants |
| Number of participants with the indicated anamnestic thromboembolisms None | 79 participants |
| Number of participants with the indicated anamnestic thromboembolisms Venous only | 39 participants |
| Number of participants with the indicated number of former abortions 1 | 27 participants |
| Number of participants with the indicated number of former abortions 2 | 16 participants |
| Number of participants with the indicated number of former abortions 3 | 2 participants |
| Number of participants with the indicated number of former abortions 4 | 2 participants |
| Number of participants with the indicated number of former abortions 6 | 1 participants |
| Number of participants with the indicated number of former abortions Missing data | 3 participants |
| Number of participants with the indicated number of former abortions Total | 51 participants |
| Number of participants with the indicated number of former pregnancies 0 | 35 participants |
| Number of participants with the indicated number of former pregnancies 1 | 43 participants |
| Number of participants with the indicated number of former pregnancies 10 | 1 participants |
| Number of participants with the indicated number of former pregnancies 2 | 19 participants |
| Number of participants with the indicated number of former pregnancies 3 | 15 participants |
| Number of participants with the indicated number of former pregnancies 4 | 3 participants |
| Number of participants with the indicated number of former pregnancies 5 | 2 participants |
| Number of participants with the indicated number of former pregnancies 6 | 1 participants |
| Number of participants with the indicated number of former pregnancies Missing | 1 participants |
| Number of participants with the indicated reason for the end of LMWH administration Allergy to heparin | 39 participants |
| Number of participants with the indicated reason for the end of LMWH administration Change to another antithrombotic agent | 44 participants |
| Number of participants with the indicated reason for the end of LMWH administration End of thromboembolism prophylaxis/therapy | 3 participants |
| Number of participants with the indicated reason for the end of LMWH administration Missing | 44 participants |
| Number of participants with the indicated reason for the end of LMWH administration Other | 19 participants |
| Number of participants with the indicated reason for the end of LMWH administration Thrombocytopenia | 7 participants |
| Number of participants with the indicated reason for the end of LMWH administration Total | 120 participants |
| Number of participants with the indicated reason for the end of UFH administration Allergy to heparin | 2 participants |
| Number of participants with the indicated reason for the end of UFH administration Change to another antithrombotic agent | 0 participants |
| Number of participants with the indicated reason for the end of UFH administration End of thromboembolism prophylaxis/therapy | 1 participants |
| Number of participants with the indicated reason for the end of UFH administration Thrombocytopenia | 0 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Adiposity (BMI>=30) | 12 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Alcohol | 1 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Chronic inflammatory disease | 3 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Diabetes mellitus | 2 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Drug abuse | 1 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Hormonotherapy in in-vitro fertilization | 10 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Hypercholesteremia | 3 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Hypertonia | 5 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Immobilization | 5 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Malignant underlying disease | 3 participants |
| Number of participants with the indicated risk factors for venous thromboembolism None | 75 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Other | 5 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Other supportive gynaecological treatments | 8 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Previous oral contraception | 11 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Serious systemic infection | 3 participants |
| Number of participants with the indicated risk factors for venous thromboembolism Smoking | 11 participants |
| Number of participants with the indicated type of former birth All former births | 61 participants |
| Number of participants with the indicated type of former birth Children with abnormalities | 1 participants |
| Number of participants with the indicated type of former birth Healthy children | 51 participants |
| Number of participants with the indicated type of former birth Live births | 56 participants |
| Number of participants with the indicated type of former birth Missing data | 59 participants |
| Number of participants with the indicated type of former birth Still births | 6 participants |
| Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis Missing | 2 participants |
| Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis Total | 82 participants |
| Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis Without VTE in anamnesis | 58 participants |
| Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis With VTE in anamnesis | 22 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 120 | 0 / 124 |
| serious Total, serious adverse events | 9 / 120 | 1 / 124 |
Outcome results
Primary
Duration of Fondaparinux Administration
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fondaparinux | Duration of Fondaparinux Administration | 131 days |
Primary
Duration of Postnatal Fondaparinux Administration
The postnatal interval is defined as the interval of time beginning 2 days after birth.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fondaparinux | Duration of Postnatal Fondaparinux Administration | 23 days |
Primary
Duration of Prenatal Fondaparinux Administration
The prenatal interval is defined as the interval of time until 3 days before birth.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fondaparinux | Duration of Prenatal Fondaparinux Administration | 130 days |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fondaparinux | Mean APGAR Score at 1, 5, and 10 Minutes After Birth | after 1 min, n=26 | 8.6 scores on a scale | Standard Deviation 0.9 |
| Fondaparinux | Mean APGAR Score at 1, 5, and 10 Minutes After Birth | after 5 min, n=27 | 9.1 scores on a scale | Standard Deviation 0.7 |
| Fondaparinux | Mean APGAR Score at 1, 5, and 10 Minutes After Birth | after 10 min, n=27 | 9.6 scores on a scale | Standard Deviation 0.5 |
Primary
Mean Head Circumference of Newborn
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fondaparinux | Mean Head Circumference of Newborn | 34 centimeters | Standard Deviation 2.2 |
Primary
Mean Height of Newborn
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fondaparinux | Mean Height of Newborn | 49.6 centimeters | Standard Deviation 3.8 |
Primary
Mean Weight of Newborn
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fondaparinux | Mean Weight of Newborn | 3042 grams | Standard Deviation 662.6 |
Primary
Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fondaparinux | Number of Hours After Birth at Which Fondaparinux Administration Was Restarted | 11.3 hours | Standard Deviation 5.2 |
Primary
Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fondaparinux | Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered | 34.6 hours | Standard Deviation 10.8 |
Primary
Number of Newborns Who Had a Healthy Postnatal Classification
A healthy documentation was based on the investigators' individual assessment.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Newborns Who Had a Healthy Postnatal Classification | Missing data | 10 newborns |
| Fondaparinux | Number of Newborns Who Had a Healthy Postnatal Classification | Healthy | 110 newborns |
| Fondaparinux | Number of Newborns Who Had a Healthy Postnatal Classification | Not healthy | 4 newborns |
Primary
Number of Newborns With Abnormalities
No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Newborns With Abnormalities | Missing data | 10 newborns |
| Fondaparinux | Number of Newborns With Abnormalities | No abnormalities | 114 newborns |
Primary
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | 5 mg | 16 participants |
| Fondaparinux | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | Dose missing | 2 participants |
| Fondaparinux | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | 2.5 milligrams (mg) | 94 participants |
| Fondaparinux | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | 5 mg until delivery, followed by 2.5 mg | 1 participants |
| Fondaparinux | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | 7.5 mg | 3 participants |
| Fondaparinux | Number of Participants Administered the Indicated Dose of Fondaparinux Per Day | 10 mg | 4 participants |
Primary
Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth | Missing data | 9 participants |
| Fondaparinux | Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth | Not interrupted | 20 participants |
| Fondaparinux | Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth | Interrupted | 91 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Prenatal only | 6 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Perinatal only | 0 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Postnatal only | 1 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Prenatal and Perinatal | 3 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Perinatal and Postnatal | 1 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Prenatal and Postnatal | 2 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Prenatal, Perinatal, and Postnatal | 97 participants |
| Fondaparinux | Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals | Unknown | 10 participants |
Primary
Number of Participants Who Delivered a Single Child Versus Twins
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants Who Delivered a Single Child Versus Twins | Single child | 116 participants |
| Fondaparinux | Number of Participants Who Delivered a Single Child Versus Twins | Twins | 4 participants |
Primary
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | Missing data | 11 participants |
| Fondaparinux | Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | Spontaneous | 71 participants |
| Fondaparinux | Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | Induced | 3 participants |
| Fondaparinux | Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | Caesarian section | 34 participants |
| Fondaparinux | Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth | Induced/Caesarian section | 1 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Heparin-induced thrombocytopenia (HIT) | 12 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Allergy to heparin | 50 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Other intolerances | 3 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Lack of compliance | 3 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Fix dose | 0 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | No monitoring of thrombocyte count necessary | 16 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Medical decision because of other reasons | 42 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for Change to Fondaparinux | Other reasons | 47 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | Missing data | 18 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | End of thromboembolism prophylaxis/therapy | 94 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | Change to another antithrombotic agent | 6 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | Thrombocytopenia (HIT II) | 0 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | Allergic reaction | 0 participants |
| Fondaparinux | Number of Participants With the Indicated Reason for the End of Fondaparinux Administration | Other reasons | 5 participants |
Primary
Number of Participants With the Indicated Type of Conception/Fertilization
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With the Indicated Type of Conception/Fertilization | Missing | 2 participants |
| Fondaparinux | Number of Participants With the Indicated Type of Conception/Fertilization | Normal conception | 107 participants |
| Fondaparinux | Number of Participants With the Indicated Type of Conception/Fertilization | Induced pregnancy with normal conception | 1 participants |
| Fondaparinux | Number of Participants With the Indicated Type of Conception/Fertilization | In-vitro fertilization | 10 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fondaparinux | Duration From Start of Fondaparinux Therapy to HIT | 15 days |
Secondary
Duration From Start of UFH/LMWH Therapy to HIT
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fondaparinux | Duration From Start of UFH/LMWH Therapy to HIT | 27.5 days |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fondaparinux | Duration From Start of UFH/LMWH Therapy to Skin Change | 42 days |
Secondary
Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fondaparinux | Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration | 5 days |
Secondary
Duration of Hospitalizations Before, During, and After Fondaparinux Administration
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fondaparinux | Duration of Hospitalizations Before, During, and After Fondaparinux Administration | Before Fondaparinux, n=3 | 10 days |
| Fondaparinux | Duration of Hospitalizations Before, During, and After Fondaparinux Administration | During Fondaparinux, n=5 | 5 days |
| Fondaparinux | Duration of Hospitalizations Before, During, and After Fondaparinux Administration | After Fondaparinux, n=1 | 2 days |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants Hospitalized Because of Thromboembolic Treatment | Total | 120 participants |
| Fondaparinux | Number of Participants Hospitalized Because of Thromboembolic Treatment | Not hospitalized | 102 participants |
| Fondaparinux | Number of Participants Hospitalized Because of Thromboembolic Treatment | Hospitalized | 18 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy | Total | 40 participants |
| Fondaparinux | Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy | No erythema or missing data | 4 participants |
| Fondaparinux | Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy | Erythema | 36 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy | Total | 40 participants |
| Fondaparinux | Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy | No skin necrosis or missing data | 32 participants |
| Fondaparinux | Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy | Skin necrosis | 8 participants |
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).
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With and Without Complications Under Fondaparinux Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With and Without Complications Under Fondaparinux Therapy | No complications or missing data | 111 participants |
| Fondaparinux | Number of Participants With and Without Complications Under Fondaparinux Therapy | Complications | 9 participants |
Secondary
Number of Participants With Bleedings Under Fondaparinux Therapy
No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Bleedings Under Fondaparinux Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Bleedings Under Fondaparinux Therapy | No bleedings or missing data | 118 participants |
| Fondaparinux | Number of Participants With Bleedings Under Fondaparinux Therapy | Bleedings | 2 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Bleedings Under UFH/LMWH Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Bleedings Under UFH/LMWH Therapy | No bleeding or missing data | 118 participants |
| Fondaparinux | Number of Participants With Bleedings Under UFH/LMWH Therapy | Bleeding | 2 participants |
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).
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Complications Under UFH/LMWH Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Complications Under UFH/LMWH Therapy | Missing data | 40 participants |
| Fondaparinux | Number of Participants With Complications Under UFH/LMWH Therapy | No complications | 31 participants |
| Fondaparinux | Number of Participants With Complications Under UFH/LMWH Therapy | Complications | 49 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy | HIT II | 1 participants |
| Fondaparinux | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy | No HIT II or missing data | 119 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy | No HIT II or missing data | 111 participants |
| Fondaparinux | Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy | HIT II | 9 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Skin Changes Under Fondaparinux Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Skin Changes Under Fondaparinux Therapy | No skin changes or missing data | 120 participants |
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.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Skin Changes Under UFH/LMWH Therapy | No skin changes or missing data | 80 participants |
| Fondaparinux | Number of Participants With Skin Changes Under UFH/LMWH Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Skin Changes Under UFH/LMWH Therapy | Skin changes | 40 participants |
Secondary
Number of Participants With Thromboembolisms Under Fondaparinux Therapy
Any sign of thromboembolism as indicated by investigator was measured.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Thromboembolisms Under Fondaparinux Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Thromboembolisms Under Fondaparinux Therapy | Either missing data or no thromboembolisms | 120 participants |
Secondary
Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
Any sign of thromboembolism as indicated by investigator was measured.
Time frame: 4 months (all cases occurred between 2004 and 2010)
Population: Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fondaparinux | Number of Participants With Thromboembolisms Under UFH/LMWH Therapy | Total | 120 participants |
| Fondaparinux | Number of Participants With Thromboembolisms Under UFH/LMWH Therapy | No thromboembolism or missing data | 118 participants |
| Fondaparinux | Number of Participants With Thromboembolisms Under UFH/LMWH Therapy | Thromboembolisms | 2 participants |