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Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss (OTTILIA)

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ClinicalTrials.gov Identifier: NCT02385461
Recruitment Status : Recruiting
First Posted : March 11, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Elvira Grandone, MD, Head of Unit, Casa Sollievo della Sofferenza IRCCS

Brief 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


Condition or disease Intervention/treatment
Pregnancy Complications Drug: Low Molecular Weight Heparins (LMWHs)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Months
Official Title: A Proposal of a Prospective Study on Prevention of Pregnancy Loss in Women Carrying Inherited Thrombophilia
Study Start Date : January 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin

Group/Cohort Intervention/treatment
Inherited Thrombophilia
Women with Common Inherited Thrombophilias and previous foetal loss
Drug: Low Molecular Weight Heparins (LMWHs)
Other Thrombophilias with Pregnancy loss
Women with Thrombophilias other than common inherited thrombophilias and previous foetal loss
Drug: Low Molecular Weight Heparins (LMWHs)
No thrombophilia
Women without thrombophilias and previous foetal loss
Drug: Low Molecular Weight Heparins (LMWHs)



Primary Outcome Measures :
  1. Number of live births [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive pregnant women with previous pregnancy loss
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385461


Contacts
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Contact: Michela Villani 0039 0 882416273 mvillani27@libero.it
Contact: Donatella Colaizzo, Biol Sc 0039 0 882416283 d.colaizzo@operapadrepio.it

Locations
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Italy
I.R.C.C.S. Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Contact: Michela Villani         
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Investigators
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Principal Investigator: Elvira Grandone, MD Thrombosis Unit, I.R.C.C.S. Casa Sollievo della Sofferenza, S. Giovanni Rotondo (Foggia)

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elvira Grandone, MD, Head of Unit, A proposal of a prospective study on prevention of pregnancy loss in women carrying inherited thrombophilia., Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT02385461     History of Changes
Other Study ID Numbers: EMOST 01/2011
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Pregnancy Complications
Thrombophilia
Hematologic Diseases
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action