Trial Outcomes & Findings for Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism (NCT NCT01004939)
NCT ID: NCT01004939
Last Updated: 2011-08-26
Results Overview
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.
COMPLETED
120 participants
4 months (all cases occurred between 2004 and 2010)
2011-08-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism
Baseline characteristics by cohort
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Age Continuous
|
31.5 Years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.5 kilograms (kg)/meters squared (m^2)
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Number of participants with the indicated anamnestic thromboembolisms
None
|
79 participants
n=5 Participants
|
|
Number of participants with the indicated anamnestic thromboembolisms
Arterial only
|
0 participants
n=5 Participants
|
|
Number of participants with the indicated anamnestic thromboembolisms
Venous only
|
39 participants
n=5 Participants
|
|
Number of participants with the indicated anamnestic thromboembolisms
Both arterial and venous
|
2 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
None
|
20 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Protein C deficiency
|
5 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Protein S deficiency
|
10 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Antithrombin deficiency
|
2 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Factor V Leiden mutation heterozygous
|
13 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Factor V Leiden mutation homozygous
|
0 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Prothrombin mutation heterozygous
|
13 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Prothombin mutation homozygous
|
0 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Antiphospholipid syndrome
|
15 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Persistant factor VIII increase
|
4 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Factor VII activating protease (FSAP)
|
6 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Factor VII C46T
|
18 participants
n=5 Participants
|
|
Number of participants with known thrombophilia
Other
|
46 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
None
|
75 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Previous oral contraception
|
11 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Hormonotherapy in in-vitro fertilization
|
10 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Other supportive gynaecological treatments
|
8 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Malignant underlying disease
|
3 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Adiposity (BMI>=30)
|
12 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Smoking
|
11 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Alcohol
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Drug abuse
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Chronic inflammatory disease
|
3 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Serious systemic infection
|
3 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Immobilization
|
5 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Diabetes mellitus
|
2 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Hypercholesteremia
|
3 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Hypertonia
|
5 participants
n=5 Participants
|
|
Number of participants with the indicated risk factors for venous thromboembolism
Other
|
5 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
Missing
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
0
|
35 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
1
|
43 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
2
|
19 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
3
|
15 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
4
|
3 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
5
|
2 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
6
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated number of former pregnancies
10
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated type of former birth
Missing data
|
59 participants
n=5 Participants
|
|
Number of participants with the indicated type of former birth
All former births
|
61 participants
n=5 Participants
|
|
Number of participants with the indicated type of former birth
Still births
|
6 participants
n=5 Participants
|
|
Number of participants with the indicated type of former birth
Live births
|
56 participants
n=5 Participants
|
|
Number of participants with the indicated type of former birth
Healthy children
|
51 participants
n=5 Participants
|
|
Number of participants with the indicated type of former birth
Children with abnormalities
|
1 participants
n=5 Participants
|
|
Number of participants who indicated that they did or did not have former abortions
Total
|
85 participants
n=5 Participants
|
|
Number of participants who indicated that they did or did not have former abortions
Yes
|
32 participants
n=5 Participants
|
|
Number of participants who indicated that they did or did not have former abortions
No
|
51 participants
n=5 Participants
|
|
Number of participants who indicated that they did or did not have former abortions
Missing data
|
2 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
Total
|
51 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
1
|
27 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
2
|
16 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
3
|
2 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
4
|
2 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
6
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated number of former abortions
Missing data
|
3 participants
n=5 Participants
|
|
Number of participants undergoing either prophylaxis or therapy
Prophylaxis
|
111 participants
n=5 Participants
|
|
Number of participants undergoing either prophylaxis or therapy
Therapy
|
11 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of prophylactic treatment
Prophylaxis: thromboembolic risk
|
99 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of prophylactic treatment
Prophylaxis: surgery
|
5 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of prophylactic treatment
Prophylaxis: internal medicine
|
31 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Data missing
|
1 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Therapy: deep vein thrombosis
|
7 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Therapy: pulmonary embolism
|
3 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Peripheral arterial disease
|
0 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Acute coronary syndrome
|
0 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Alternative anticoagulation at atrial fibrilation
|
0 participants
n=5 Participants
|
|
Number of participants receiving therapeutic treatment for the given indications
Alternative anticoagulation at heart valve
|
1 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
Thrombophilia
|
82 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
VTE in anamnesis
|
33 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
Women with >=2 risk factors
|
9 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
Long-time anticoagulation with oral anticoagulants
|
4 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
Antiphospholipid syndrome
|
14 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
Antithrombine deficiency
|
3 participants
n=5 Participants
|
|
Number of participants receiving thromboembolic prophylaxis for the given indications
Acute VTE during pregnancy
|
1 participants
n=5 Participants
|
|
Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis
Total
|
82 participants
n=5 Participants
|
|
Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis
Missing
|
2 participants
n=5 Participants
|
|
Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis
Without VTE in anamnesis
|
58 participants
n=5 Participants
|
|
Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis
With VTE in anamnesis
|
22 participants
n=5 Participants
|
|
Number of participants who did and did not receive UFH
Did not receive UFH
|
117 participants
n=5 Participants
|
|
Number of participants who did and did not receive UFH
Received UFH
|
3 participants
n=5 Participants
|
|
Duration of UFH administration
|
32 days
n=5 Participants
|
|
Number of participants with the indicated reason for the end of UFH administration
End of thromboembolism prophylaxis/therapy
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of UFH administration
Change to another antithrombotic agent
|
0 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of UFH administration
Thrombocytopenia
|
0 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of UFH administration
Allergy to heparin
|
2 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Total
|
120 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Missing
|
45 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Enoxaparin
|
28 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Nadroparin
|
21 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Dalteparin
|
35 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Certoparin
|
1 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Tinzaparin
|
0 participants
n=5 Participants
|
|
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH)
Reviparin
|
0 participants
n=5 Participants
|
|
Duration of LMWH administration
|
54 days
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
Total
|
120 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
Missing
|
44 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
End of thromboembolism prophylaxis/therapy
|
3 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
Change to another antithrombotic agent
|
44 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
Thrombocytopenia
|
7 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
Allergy to heparin
|
39 participants
n=5 Participants
|
|
Number of participants with the indicated reason for the end of LMWH administration
Other
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Prenatal only
|
6 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Perinatal only
|
0 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Postnatal only
|
1 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Prenatal and Perinatal
|
3 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Perinatal and Postnatal
|
1 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Prenatal and Postnatal
|
2 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Prenatal, Perinatal, and Postnatal
|
97 participants
|
|
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
Unknown
|
10 participants
|
PRIMARY outcome
Timeframe: 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
It was possible for a participant to have changed to fondaparinux for multiple reasons.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Heparin-induced thrombocytopenia (HIT)
|
12 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Allergy to heparin
|
50 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Other intolerances
|
3 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Lack of compliance
|
3 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Fix dose
|
0 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
No monitoring of thrombocyte count necessary
|
16 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Medical decision because of other reasons
|
42 participants
|
|
Number of Participants With the Indicated Reason for Change to Fondaparinux
Other reasons
|
47 participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
Dose missing
|
2 participants
|
|
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
2.5 milligrams (mg)
|
94 participants
|
|
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
5 mg
|
16 participants
|
|
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
5 mg until delivery, followed by 2.5 mg
|
1 participants
|
|
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
7.5 mg
|
3 participants
|
|
Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
10 mg
|
4 participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=101 Participants
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.
|
|---|---|
|
Duration of Fondaparinux Administration
|
131 days
Interval 2.0 to 1392.0
|
PRIMARY outcome
Timeframe: 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.
The prenatal interval is defined as the interval of time until 3 days before birth.
Outcome measures
| Measure |
Fondaparinux
n=99 Participants
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.
|
|---|---|
|
Duration of Prenatal Fondaparinux Administration
|
130 days
Interval 5.0 to 468.0
|
PRIMARY outcome
Timeframe: 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.
The postnatal interval is defined as the interval of time beginning 2 days after birth.
Outcome measures
| Measure |
Fondaparinux
n=90 Participants
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.
|
|---|---|
|
Duration of Postnatal Fondaparinux Administration
|
23 days
Interval 11.0 to 41.0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
Missing data
|
9 participants
|
|
Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
Not interrupted
|
20 participants
|
|
Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
Interrupted
|
91 participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=45 Participants
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.
|
|---|---|
|
Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
|
34.6 hours
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=86 Participants
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.
|
|---|---|
|
Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
|
11.3 hours
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: 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
It is possible that a participant stopped receiving Fondaparinux for multiple reasons.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
Missing data
|
18 participants
|
|
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
End of thromboembolism prophylaxis/therapy
|
94 participants
|
|
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
Change to another antithrombotic agent
|
6 participants
|
|
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
Thrombocytopenia (HIT II)
|
0 participants
|
|
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
Allergic reaction
|
0 participants
|
|
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
Other reasons
|
5 participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Missing data
|
11 participants
|
|
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Spontaneous
|
71 participants
|
|
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Induced
|
3 participants
|
|
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Caesarian section
|
34 participants
|
|
Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
Induced/Caesarian section
|
1 participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With the Indicated Type of Conception/Fertilization
Missing
|
2 participants
|
|
Number of Participants With the Indicated Type of Conception/Fertilization
Normal conception
|
107 participants
|
|
Number of Participants With the Indicated Type of Conception/Fertilization
Induced pregnancy with normal conception
|
1 participants
|
|
Number of Participants With the Indicated Type of Conception/Fertilization
In-vitro fertilization
|
10 participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants Who Delivered a Single Child Versus Twins
Single child
|
116 participants
|
|
Number of Participants Who Delivered a Single Child Versus Twins
Twins
|
4 participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=63 newborns
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.
|
|---|---|
|
Mean Weight of Newborn
|
3042 grams
Standard Deviation 662.6
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=37 newborns
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.
|
|---|---|
|
Mean Height of Newborn
|
49.6 centimeters
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=27 newborns
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.
|
|---|---|
|
Mean Head Circumference of Newborn
|
34 centimeters
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Fondaparinux
n=27 newborns
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.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
A "healthy" documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=124 newborns
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.
|
|---|---|
|
Number of Newborns Who Had a "Healthy" Postnatal Classification
Missing data
|
10 newborns
|
|
Number of Newborns Who Had a "Healthy" Postnatal Classification
Healthy
|
110 newborns
|
|
Number of Newborns Who Had a "Healthy" Postnatal Classification
Not healthy
|
4 newborns
|
PRIMARY outcome
Timeframe: 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
No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=124 newborns
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.
|
|---|---|
|
Number of Newborns With Abnormalities
Missing data
|
10 newborns
|
|
Number of Newborns With Abnormalities
No abnormalities
|
114 newborns
|
SECONDARY outcome
Timeframe: 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
Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants Hospitalized Because of Thromboembolic Treatment
Total
|
120 participants
|
|
Number of Participants Hospitalized Because of Thromboembolic Treatment
Not hospitalized
|
102 participants
|
|
Number of Participants Hospitalized Because of Thromboembolic Treatment
Hospitalized
|
18 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=9 Participants
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.
|
|---|---|
|
Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration
|
5 days
Interval 2.0 to 28.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=5 Participants
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.
|
|---|---|
|
Duration of Hospitalizations Before, During, and After Fondaparinux Administration
Before Fondaparinux, n=3
|
10 days
Interval 2.0 to 28.0
|
|
Duration of Hospitalizations Before, During, and After Fondaparinux Administration
During Fondaparinux, n=5
|
5 days
Interval 2.0 to 10.0
|
|
Duration of Hospitalizations Before, During, and After Fondaparinux Administration
After Fondaparinux, n=1
|
2 days
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: 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
A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Complications Under UFH/LMWH Therapy
Total
|
120 participants
|
|
Number of Participants With Complications Under UFH/LMWH Therapy
Missing data
|
40 participants
|
|
Number of Participants With Complications Under UFH/LMWH Therapy
No complications
|
31 participants
|
|
Number of Participants With Complications Under UFH/LMWH Therapy
Complications
|
49 participants
|
SECONDARY outcome
Timeframe: 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
Any sign of thromboembolism as indicated by investigator was measured.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
Total
|
120 participants
|
|
Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
No thromboembolism or missing data
|
118 participants
|
|
Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
Thromboembolisms
|
2 participants
|
SECONDARY outcome
Timeframe: 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
No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Bleedings Under UFH/LMWH Therapy
Total
|
120 participants
|
|
Number of Participants With Bleedings Under UFH/LMWH Therapy
No bleeding or missing data
|
118 participants
|
|
Number of Participants With Bleedings Under UFH/LMWH Therapy
Bleeding
|
2 participants
|
SECONDARY outcome
Timeframe: 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
No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Skin Changes Under UFH/LMWH Therapy
Total
|
120 participants
|
|
Number of Participants With Skin Changes Under UFH/LMWH Therapy
No skin changes or missing data
|
80 participants
|
|
Number of Participants With Skin Changes Under UFH/LMWH Therapy
Skin changes
|
40 participants
|
SECONDARY outcome
Timeframe: 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.
No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=27 Participants
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.
|
|---|---|
|
Duration From Start of UFH/LMWH Therapy to Skin Change
|
42 days
Interval 3.0 to 134.0
|
SECONDARY outcome
Timeframe: 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.
Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.
Outcome measures
| Measure |
Fondaparinux
n=40 Participants
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.
|
|---|---|
|
Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy
Total
|
40 participants
|
|
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
|
|
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 outcome
Timeframe: 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.
Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.
Outcome measures
| Measure |
Fondaparinux
n=40 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy
Total
|
120 participants
|
|
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy
No HIT II or missing data
|
111 participants
|
|
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy
HIT II
|
9 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fondaparinux
n=8 Participants
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.
|
|---|---|
|
Duration From Start of UFH/LMWH Therapy to HIT
|
27.5 days
Interval 3.0 to 576.0
|
SECONDARY outcome
Timeframe: 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
A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With and Without Complications Under Fondaparinux Therapy
Total
|
120 participants
|
|
Number of Participants With and Without Complications Under Fondaparinux Therapy
No complications or missing data
|
111 participants
|
|
Number of Participants With and Without Complications Under Fondaparinux Therapy
Complications
|
9 participants
|
SECONDARY outcome
Timeframe: 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
Any sign of thromboembolism as indicated by investigator was measured.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Thromboembolisms Under Fondaparinux Therapy
Total
|
120 participants
|
|
Number of Participants With Thromboembolisms Under Fondaparinux Therapy
Either missing data or no thromboembolisms
|
120 participants
|
SECONDARY outcome
Timeframe: 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
No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Bleedings Under Fondaparinux Therapy
Total
|
120 participants
|
|
Number of Participants With Bleedings Under Fondaparinux Therapy
No bleedings or missing data
|
118 participants
|
|
Number of Participants With Bleedings Under Fondaparinux Therapy
Bleedings
|
2 participants
|
SECONDARY outcome
Timeframe: 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
No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Skin Changes Under Fondaparinux Therapy
Total
|
120 participants
|
|
Number of Participants With Skin Changes Under Fondaparinux Therapy
No skin changes or missing data
|
120 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Fondaparinux
n=120 Participants
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.
|
|---|---|
|
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy
Total
|
120 participants
|
|
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy
No HIT II or missing data
|
119 participants
|
|
Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy
HIT II
|
1 participants
|
SECONDARY outcome
Timeframe: 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.
For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.
Outcome measures
| Measure |
Fondaparinux
n=1 Participants
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.
|
|---|---|
|
Duration From Start of Fondaparinux Therapy to HIT
|
15 days
|
Adverse Events
Fondaparinux - Mother
Fondaparinux - Child
Serious adverse events
| Measure |
Fondaparinux - Mother
n=120 participants at risk
Events reported for mothers receiving Fondaparinux
|
Fondaparinux - Child
n=124 participants at risk
Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.3%
4/120
|
0.00%
0/124
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.83%
1/120
|
0.00%
0/124
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.83%
1/120
|
0.00%
0/124
|
|
Surgical and medical procedures
Abortion induced
|
0.83%
1/120
|
0.00%
0/124
|
|
Vascular disorders
Haemorrhage
|
0.83%
1/120
|
0.00%
0/124
|
|
General disorders
Heparin-induced thrombocytopenia
|
0.83%
1/120
|
0.00%
0/124
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.83%
1/120
|
0.00%
0/124
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.83%
1/120
|
0.00%
0/124
|
|
Congenital, familial and genetic disorders
Trisomy 18
|
0.00%
0/120
|
0.81%
1/124
|
|
Investigations
Transaminases increased
|
0.00%
0/120
|
0.00%
0/124
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.83%
1/120
|
0.00%
0/124
|
Other adverse events
| Measure |
Fondaparinux - Mother
n=120 participants at risk
Events reported for mothers receiving Fondaparinux
|
Fondaparinux - Child
n=124 participants at risk
Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
|
|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
5.0%
6/120
|
0.00%
0/124
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER