Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss

NCT02385461 | Unknown DMC

• 1 other identifier: EMOST 01/2011
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Number of live births

  10 months

Study Arms (3)

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)

Interventions

Low Molecular Weight Heparins (LMWHs) DRUG

Inherited Thrombophilia; No thrombophilia; Other Thrombophilias with Pregnancy loss

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Consecutive pregnant women with previous pregnancy loss

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Casa Sollievo della Sofferenza IRCCS: lead

Study Sites (1)

I.R.C.C.S. Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Related Publications (2)

• Grandone E, Tiscia GL, Mastroianno M, Larciprete G, Kovac M, Tamborini Permunian E, Lojacono A, Barcellona D, Bitsadze V, Khizroeva J, Makatsarya A, Cacciola R, Martinelli I, Bucherini E, De Stefano V, Lodigiani C, Colaizzo D, De Laurenzo A, Piazza G, Margaglione M. Findings from a multicentre, observational study on reproductive outcomes in women with unexplained recurrent pregnancy loss: the OTTILIA registry. Hum Reprod. 2021 Jul 19;36(8):2083-2090. doi: 10.1093/humrep/deab153.

  PMID: 34195794 DERIVED

• Villani M, Baldini D, Totaro P, Larciprete G, Kovac M, Carone D, Passamonti SM, Permunian ET, Bartolotti T, Lojacono A, Cacciola R, Pinto GL, Bucherini E, De Stefano V, Lodigiani C, Lavopa C, Cho YS, Pizzicaroli C, Colaizzo D, Grandone E. Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):292. doi: 10.1186/s12884-019-2444-y.

  PMID: 31409287 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Elvira Grandone, MD

  Thrombosis Unit, I.R.C.C.S. Casa Sollievo della Sofferenza, S. Giovanni Rotondo (Foggia)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michela Villani

CONTACT

0039 0 882416273; mvillani27@libero.it

Donatella Colaizzo, Biol Sc

CONTACT

0039 0 882416283; d.colaizzo@operapadrepio.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A proposal of a prospective study on prevention of pregnancy loss in women carrying inherited thrombophilia.

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: January 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

IT (1)