Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss
Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss
The occurrence of a spontaneous fetal loss (FL) is a rather frequent event: it has been
 estimated that up to 15% of pregnancies result in a fetal loss. However, recurrent events,
 defined as >2 or >3 loss, depending on the guidelines used (American College of Obstetricians
 and Gynecologists or Royal College of Obstetricians Gynaecologists guidelines), occur in 1 %
 of all pregnancies and it is noteworthy that Recurrent Fetal Loss ( RFL) in about 30-40% of
 cases remain unexplained after standard gynaecological, hormonal and karyotype
 investigations. Furthermore, it is important to consider that chromosomal abnormalities are
 responsible for at least 60% of FL in the first trimester, thus an abnormal karyotype in the
 fetus should be excluded prior to consider testing women for genetic susceptibility to
 placental vascular complications (inherited thrombophilia).

 Common inherited conditions, the factor V Leiden (FV) and the factor II G20210A (FII)
 mutations have been recognized as risk factors for FL.

 The efficacy of treatment with antithrombotic drugs during pregnancy in women with a history
 of RFL/ Intra Uterine Fetal Death (IUFD) and thrombophilia is still debated, due to scarcity
 of available data. Italian guidelines suggest the use of Low-Molecular-Weight Heparin (LMWH)
 in women with FV or FII mutations and previous otherwise unexplained obstetric complications,
 while guidelines released by RCOG suggest that heparin therapy during pregnancy may improve
 the live birth rate in women with second trimester loss associated with inherited
 thrombophilias. Hence, the idea to propose this prospective observational study comparing
 clinical data and outcomes in women with common inherited thrombophilias and in women
 without.

 During this study the investigators will collect and evaluate clinical data from examinations
 and visits by patients, eligible for the study as carriers of thrombophilic defects. This
 observation will begin before pregnancy and continue until the puerperium, allowing us to
 study all possible factors influencing these conditions. The study will add knowledge for
 improving feto-maternal prognosis and preventing spontaneous and recurrent FL.

 Plan of the study: multicenter observational study
Inclusion Criteria:

 -  recurrent otherwise unexplained FL (defined as >3, or 2 in the presence of at least 1
 normal fetal karyotype) (according to Lussana et al.) or

 -  at least 1 intrauterine fetal death (IUFD), defined as a loss after 20 weeks of a
 morphologically normal fetus with/without HETEROZYGOUS FOR FACTOR V LEIDEN or
 HETEROZYGOUS FOR FIIA20210 (PTm)

 Exclusion Criteria:

 -  personal history of venous and/or arterial thromboembolism;

 -  documented hemorrhagic disease;

 -  allergy to LMWH;

 -  uterine abnormalities;

 -  cervical incompetence;

 -  untreated endocrine diseases (diabetes mellitus or thyroid disease);

 -  indication to anticoagulant treatment during pregnancy;

 -  chromosomal abnormalities in parents