Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism (FondaPPP)

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01004939

First received: October 1, 2009

Last updated: July 28, 2011

Last verified: July 2011

History of Changes

Results First Received: June 30, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Conditions:	Thromboembolism Venous Thromboembolism
Intervention:	Drug: fondaparinux

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Fondaparinux
STARTED	120
COMPLETED	120
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Fondaparinux
Number of Participants [units: participants]	120
Age [units: Years] Mean ± Standard Deviation	31.5 ± 5.4
Gender [units: Participants]
Female	120
Male	0
Body Mass Index (BMI) ^[1] [units: kilograms (kg)/meters squared (m^2)] Mean ± Standard Deviation	26.5 ± 6.2
Number of participants with the indicated anamnestic thromboembolisms ^[2] [units: participants]
None	79
Arterial only	0
Venous only	39
Both arterial and venous	2
Number of participants with known thrombophilia ^[3] [units: participants]
None	20
Protein C deficiency	5
Protein S deficiency	10
Antithrombin deficiency	2
Factor V Leiden mutation heterozygous	13
Factor V Leiden mutation homozygous	0
Prothrombin mutation heterozygous	13
Prothombin mutation homozygous	0
Antiphospholipid syndrome	15
Persistant factor VIII increase	4
Factor VII activating protease (FSAP)	6
Factor VII C46T	18
Other	46
Number of participants with the indicated risk factors for venous thromboembolism ^[4] [units: participants]
None	75
Previous oral contraception	11
Hormonotherapy in in-vitro fertilization	10
Other supportive gynaecological treatments	8
Malignant underlying disease	3
Adiposity (BMI>=30)	12
Smoking	11
Alcohol	1
Drug abuse	1
Chronic inflammatory disease	3
Serious systemic infection	3
Immobilization	5
Diabetes mellitus	2
Hypercholesteremia	3
Hypertonia	5
Other	5
Number of participants with the indicated number of former pregnancies [units: participants]
Missing	1
0	35
1	43
2	19
3	15
4	3
5	2
6	1
10	1
Number of participants with the indicated type of former birth ^[5] [units: participants]
Missing data	59
All former births	61
Still births	6
Live births	56
Healthy children	51
Children with abnormalities	1
Number of participants who indicated that they did or did not have former abortions ^[6] [units: participants]
Total	85
Yes	32
No	51
Missing data	2
Number of participants with the indicated number of former abortions ^[7] [units: participants]
Total	51
1	27
2	16
3	2
4	2
6	1
Missing data	3
Number of participants undergoing either prophylaxis or therapy ^[8] [units: participants]
Prophylaxis	111
Therapy	11
Number of participants receiving the indicated type of prophylactic treatment ^[9] [units: participants]
Prophylaxis: thromboembolic risk	99
Prophylaxis: surgery	5
Prophylaxis: internal medicine	31
Number of participants receiving therapeutic treatment for the given indications ^[10] [units: participants]
Data missing	1
Therapy: deep vein thrombosis	7
Therapy: pulmonary embolism	3
Peripheral arterial disease	0
Acute coronary syndrome	0
Alternative anticoagulation at atrial fibrilation	0
Alternative anticoagulation at heart valve	1
Number of participants receiving thromboembolic prophylaxis for the given indications ^[11] [units: participants]
Thrombophilia	82
VTE in anamnesis	33
Women with >=2 risk factors	9
Long-time anticoagulation with oral anticoagulants	4
Antiphospholipid syndrome	14
Antithrombine deficiency	3
Acute VTE during pregnancy	1
Number of participants with thrombophilia accompanied by venous thromboembolism (VTE) in anamnesis ^[12] [units: participants]
Total	82
Missing	2
Without VTE in anamnesis	58
With VTE in anamnesis	22
Number of participants who did and did not receive UFH ^[13] [units: participants]
Did not receive UFH	117
Received UFH	3
Duration of UFH administration [units: days] Median ( Full Range )	32 ( 7 to 102 )
Number of participants with the indicated reason for the end of UFH administration ^[14] [units: participants]
End of thromboembolism prophylaxis/therapy	1
Change to another antithrombotic agent	0
Thrombocytopenia	0
Allergy to heparin	2
Number of participants receiving the indicated type of low-molecular-weight heparin (LMWH) ^[14] [units: participants]
Total	120
Missing	45
Enoxaparin	28
Nadroparin	21
Dalteparin	35
Certoparin	1
Tinzaparin	0
Reviparin	0
Duration of LMWH administration [units: days] Median ( Full Range )	54 ( 4 to 1205 )
Number of participants with the indicated reason for the end of LMWH administration ^[14] [units: participants]
Total	120
Missing	44
End of thromboembolism prophylaxis/therapy	3
Change to another antithrombotic agent	44
Thrombocytopenia	7
Allergy to heparin	39
Other	19

[1]	BMI is calculated as body weight in kilograms (kg) divided by body height in meters squared (m^2)
[2]	Known anamnestic (experienced in the past) arterial and venous thromboembolisms, important dispositional risk factors, are reported. A thromboembolism is a clot in the blood that forms and blocks a blood vessel.
[3]	Thrombophilic defects, important dispositional risk factors, are reported. It is possible for a participant to have multiple responses. Thrombophilia is a genetic disorder of blood coagulation that increases the risk of thrombosis.
[4]	It is possible for a participant to have more than one of the indicated risk factors.
[5]	It is possible for a participant to have more than one type of former birth. It is possible for a participant to have multiple responses.
[6]	Participants were asked to respond “Yes” or “No” to the question: “Did you have former abortions.” Only those participants who reported a former pregnancy responded to this question.
[7]	Data were collected from only those participants who gave a response of “Yes” to the question of “Did you have former abortions.”
[8]	The number of participants receiving either antithrombotic prophylaxis (designed and used to prevent a disease from occurring) or therapy of acute venous thromboembolism was measured. It is possible for a participant to have multiple responses.
[9]	A prophylactic treatment is one that is designed and used to prevent a disease from occurring. Prophylaxis for thromboembolic risk is treatment for dispositional thromboembolic risk factors. It is possible for one participant to undergo multiple types of prophylactic treatment.
[10]	It is possible for one participant to undergo multiple types of therapeutic treatment for multiple indications.
[11]	It is possible for one participant to undergo multiple types of treatment for multiple indications. VTE, venous thromboembolis.
[12]	Thrombophilia is a genetic disorder of blood coagulation that increases the risk of thrombosis.
[13]	Unfractionated heparin (UFH) is an anticoagulant.
[14]	It is possible for one participant to have multiple responses.

Outcome Measures

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1. Primary:

Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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2. Primary:

Number of Participants With the Indicated Reason for Change to Fondaparinux [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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3. Primary:

Number of Participants Administered the Indicated Dose of Fondaparinux Per Day [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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4. Primary:

Duration of Fondaparinux Administration [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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5. Primary:

Duration of Prenatal Fondaparinux Administration [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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6. Primary:

Duration of Postnatal Fondaparinux Administration [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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7. Primary:

Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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8. Primary:

Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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9. Primary:

Number of Hours After Birth at Which Fondaparinux Administration Was Restarted [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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10. Primary:

Number of Participants With the Indicated Reason for the End of Fondaparinux Administration [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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11. 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) ]

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12. Primary:

Number of Participants With the Indicated Type of Conception/Fertilization [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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13. Primary:

Number of Participants Who Delivered a Single Child Versus Twins [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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14. Primary:

Mean Weight of Newborn [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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Measure Type	Primary
Measure Title	Mean Weight of Newborn
Measure Description	No text entered.
Time Frame	4 months (all cases occurred between 2004 and 2010)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Fondaparinux	Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.

Description

Fondaparinux

Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.

Measured Values

	Fondaparinux
Number of Participants Analyzed [units: participants]	120
Number of newborns Analyzed [units: newborns]	63
Mean Weight of Newborn [units: grams] Mean ± Standard Deviation	3042 ± 662.6

No statistical analysis provided for Mean Weight of Newborn

15. Primary:

Mean Height of Newborn [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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16. Primary:

Mean Head Circumference of Newborn [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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17. Primary:

Mean APGAR Score at 1, 5, and 10 Minutes After Birth [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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18. Primary:

Number of Newborns Who Had a “Healthy” Postnatal Classification [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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19. Primary:

Number of Newborns With Abnormalities [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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20. Secondary:

Number of Participants Hospitalized Because of Thromboembolic Treatment [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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21. Secondary:

Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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22. Secondary:

Duration of Hospitalizations Before, During, and After Fondaparinux Administration [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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23. Secondary:

Number of Participants With Complications Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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24. Secondary:

Number of Participants With Thromboembolisms Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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25. Secondary:

Number of Participants With Bleedings Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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26. Secondary:

Number of Participants With Skin Changes Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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27. Secondary:

Duration From Start of UFH/LMWH Therapy to Skin Change [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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28. Secondary:

Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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29. Secondary:

Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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30. Secondary:

Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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31. Secondary:

Duration From Start of UFH/LMWH Therapy to HIT [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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32. Secondary:

Number of Participants With and Without Complications Under Fondaparinux Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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33. Secondary:

Number of Participants With Thromboembolisms Under Fondaparinux Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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34. Secondary:

Number of Participants With Bleedings Under Fondaparinux Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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35. Secondary:

Number of Participants With Skin Changes Under Fondaparinux Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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36. Secondary:

Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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37. Secondary:

Duration From Start of Fondaparinux Therapy to HIT [ Time Frame: 4 months (all cases occurred between 2004 and 2010) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01004939 History of Changes
Other Study ID Numbers:	112937
Study First Received:	October 1, 2009
Results First Received:	June 30, 2011
Last Updated:	July 28, 2011
Health Authority:	Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

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