Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

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ClinicalTrials.gov Identifier: NCT00573118

Recruitment Status : Unknown

Verified December 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Active, not recruiting

First Posted : December 13, 2007

Last Update Posted : December 13, 2007

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

Study Description

Brief Summary:

Congenital and acquired thrombophilia were identified as risk factors for thrombosis in systemic vessels.Thrombophilias have also been recently found to be associated with preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are thought to result from thrombotic events occurring in the uteroplacental circulation. Accumulating data have established an association between elevated plasma activity of factor VIII and thrombosis although the mechanism is still not defined and elevated factor VIII activity is now regarded as being equivalent to thrombophilia.

We intend to investigatthe association between factor VIII levels and severe pregnancy complications which are considered to result from placental vascular pathology, i.e., preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of elevated factor 8 will be higher among women with pregnancy complications compared to controls.

Condition or disease
Pregnancy Complications Preeclampsia Placental Abruption Intrauterine Fetal Growth Restriction Intrauterine Fetal Death

Study Design


Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Case Control
Time Perspective:	Retrospective
Official Title:	A Retrospective Analysis of Possible Association Between Severe Pregnancy Complications and Elevated Factor VIII Plasma Activity.
Study Start Date :	January 2000
Estimated Study Completion Date :	January 2008

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Preeclampsia

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa F8 protein, human Adynovate

Genetic and Rare Diseases Information Center resources: Hemophilia A Eclampsia Hemophilia Placenta Disorder

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1 The study group included 49 patients with a previous history of one or more of the following pregnancy complications: preeclampsia (n = 17), severe IUGR (n = 13), IUFD (n = 14) or placental abruption (n = 5).
2 The control group included 49 healthy women who delivered during the study period, who did not smoke during pregnancy and in whom pregnancy and delivery were uneventful

Outcome Measures

Primary Outcome Measures :

prevalenc of elevated factor VIII [ Time Frame: RETROSPECTIVE ]

Eligibility Criteria

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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:	Non-Probability Sample

Study Population

women who had either normal pregnancy or complicated pregnancy

Criteria

Inclusion Criteria:

Women who had either normal pregnancy or complicated pregnancy.

Exclusion Criteria:

Other causes of pregnancy complication such as infections, anomalies and fetal malformations

Contacts and Locations

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): NCT00573118

Locations


Israel
Tel Avis sourasky medical center
Tel Aviv, Israel, 64239

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators


Principal Investigator:	Eli Rimon, MD	Tel Aviv medical center,Israel

More Information


Responsible Party:	Eli Rimon,MD, Tel Aviv medical center; Israel
ClinicalTrials.gov Identifier:	NCT00573118 History of Changes
Other Study ID Numbers:	FactorVIII
First Posted:	December 13, 2007 Key Record Dates
Last Update Posted:	December 13, 2007
Last Verified:	December 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:


Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5).

Additional relevant MeSH terms:


Pre-Eclampsia Hemophilia A Pregnancy Complications Fetal Growth Retardation Fetal Death Stillbirth Abruptio Placentae Hypertension, Pregnancy-Induced Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases	Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Fetal Diseases Growth Disorders Pathologic Processes Death Obstetric Labor Complications Placenta Diseases Factor VIII Coagulants

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