Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss

Pregnancy Complications Clinical Trial

— OTTILIA  

Official title:

A Proposal of a Prospective Study on Prevention of Pregnancy Loss in Women Carrying Inherited Thrombophilia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385461
• Other study ID #: EMOST 01/2011
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Casa Sollievo della Sofferenza IRCCS
• Contact: Michela Villani
• Phone: 0039 0 882416273
• Email: mvillani27[@]libero.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Thrombophilia

Intervention

Drug:
• Low Molecular Weight Heparins (LMWHs)

Locations

Country	Name	City	State
Italy	I.R.C.C.S. Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
Casa Sollievo della Sofferenza IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of live births		10 months