Pregnancy Complications Clinical Trial
Official title:
A Proposal of a Prospective Study on Prevention of Pregnancy Loss in Women Carrying Inherited Thrombophilia
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
n/a
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