Retrospektive Studie zu Patientinnen, Die pränatal, Perinatal Oder Postnatal Prophylaktisch Oder Therapeutisch Mit Fondaparinux Behandelt Wurden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Patients who were treated with fondaparinux for less than 7 days
- •Patient who were treated with fondaparinux only postpartum
研究组 & 干预措施
fondaparinux prescribed subjects
fondaparinux prescribed subjets
干预措施: fondaparinux (Drug)
结局指标
主要结局
Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
时间窗: 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
时间窗: 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
时间窗: 4 months (all cases occurred between 2004 and 2010)
Duration of Fondaparinux Administration
时间窗: 4 months (all cases occurred between 2004 and 2010)
Duration of Prenatal Fondaparinux Administration
时间窗: 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
时间窗: 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
时间窗: 4 months (all cases occurred between 2004 and 2010)
Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
时间窗: 4 months (all cases occurred between 2004 and 2010)
Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
时间窗: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
时间窗: 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
时间窗: 4 months (all cases occurred between 2004 and 2010)
Number of Participants With the Indicated Type of Conception/Fertilization
时间窗: 4 months (all cases occurred between 2004 and 2010)
Number of Participants Who Delivered a Single Child Versus Twins
时间窗: 4 months (all cases occurred between 2004 and 2010)
Mean Weight of Newborn
时间窗: 4 months (all cases occurred between 2004 and 2010)
Mean Height of Newborn
时间窗: 4 months (all cases occurred between 2004 and 2010)
Mean Head Circumference of Newborn
时间窗: 4 months (all cases occurred between 2004 and 2010)
Mean APGAR Score at 1, 5, and 10 Minutes After Birth
时间窗: 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
时间窗: 4 months (all cases occurred between 2004 and 2010)
A "healthy" documentation was based on the investigators' individual assessment.
Number of Newborns With Abnormalities
时间窗: 4 months (all cases occurred between 2004 and 2010)
No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.
次要结局
- 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))
- Number of Participants With Bleedings Under UFH/LMWH Therapy(4 months (all cases occurred between 2004 and 2010))
- Number of Participants With Skin Changes Under UFH/LMWH Therapy(4 months (all cases occurred between 2004 and 2010))
- Duration From Start of UFH/LMWH Therapy to Skin Change(4 months (all cases occurred between 2004 and 2010))
- 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))
- 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))
- Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy(4 months (all cases occurred between 2004 and 2010))
- 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))
- Number of Participants With Thromboembolisms Under Fondaparinux Therapy(4 months (all cases occurred between 2004 and 2010))
- Number of Participants With Bleedings Under Fondaparinux Therapy(4 months (all cases occurred between 2004 and 2010))
- Number of Participants With Skin Changes Under Fondaparinux Therapy(4 months (all cases occurred between 2004 and 2010))
- Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy(4 months (all cases occurred between 2004 and 2010))
- Duration From Start of Fondaparinux Therapy to HIT(4 months (all cases occurred between 2004 and 2010))