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

NCT01004939 | Completed Results

• 1 other identifier: 112937
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 7

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.

Conditions

Thromboembolism; Venous Thromboembolism

Keywords

prophylaxis; venous thromboembolism; postpartum; fondaparinux; pregnancy

Outcome Measures

Primary Outcomes (19)

• 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.

  4 months (all cases occurred between 2004 and 2010)

• 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.

  4 months (all cases occurred between 2004 and 2010)

• 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

  The prenatal interval is defined as the interval of time until 3 days before birth.

  4 months (all cases occurred between 2004 and 2010)

• Duration of Postnatal Fondaparinux Administration

  The postnatal interval is defined as the interval of time beginning 2 days after birth.

  4 months (all cases occurred between 2004 and 2010)

• 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

  It is possible that a participant stopped receiving Fondaparinux for multiple reasons.

  4 months (all cases occurred between 2004 and 2010)

• Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth

  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)

• 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)

• 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.

  4 months (all cases occurred between 2004 and 2010)

• Number of Newborns Who Had a "Healthy" Postnatal Classification

  A "healthy" documentation was based on the investigators' individual assessment.

  4 months (all cases occurred between 2004 and 2010)

• Number of Newborns With Abnormalities

  No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.

  4 months (all cases occurred between 2004 and 2010)

Secondary Outcomes (18)

• Number of Participants Hospitalized Because of Thromboembolic Treatment

  4 months (all cases occurred between 2004 and 2010)

• 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)

• Number of Participants With Thromboembolisms Under UFH/LMWH Therapy

  4 months (all cases occurred between 2004 and 2010)

Study Arms (1)

fondaparinux prescribed subjects

fondaparinux prescribed subjets

Drug: fondaparinux

Interventions

fondaparinux DRUG

fondaparinux

fondaparinux prescribed subjects

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women who received a prophylaxis against venous thromboembolism because of an elevated thromboembolic risk and who were therefore treated in a haemostaseological centre.

You may qualify if:

• 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)

You may not qualify if:

• Patients who were treated with fondaparinux for less than 7 days
• Patient who were treated with fondaparinux only postpartum

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

GSK Investigational Site

Duisburg, North Rhine-Westphalia, 47051, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48143, Germany

Location

GSK Investigational Site

Bonn, Rhineland-Palatinate, 53115, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04289, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

• Dempfle CE, Koscielny J, Lindhoff-Last E, Linnemann B, Bux-Gewehr I, Kappert G, Scholz U, Kropff S, Eberle S, Bramlage P, Heinken A. Fondaparinux Pre-, Peri-, and/or Postpartum for the Prophylaxis/Treatment of Venous Thromboembolism (FondaPPP). Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211014575. doi: 10.1177/10760296211014575.

  PMID: 33942675 DERIVED

MeSH Terms

Conditions

Thromboembolism; Venous Thromboembolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 30, 2009
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 26, 2011
• Results First Posted: August 26, 2011

Record last verified: 2011-07

Locations

DE (7)