Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT00573118

First received: December 12, 2007

Last updated: NA

Last verified: December 2007

History: No changes posted

Purpose

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
Pregnancy Complications Preeclampsia Placental Abruption Intrauterine Fetal Growth Restriction Intrauterine Fetal Death


Study Type:	Observational
Study Design:	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.

Resource links provided by NLM:

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

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

prevalenc of elevated factor VIII [ Time Frame: RETROSPECTIVE ]


Estimated Enrollment:	100
Study Start Date:	January 2000
Estimated Study Completion Date:	January 2008

Groups/Cohorts
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

Eligibility


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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	December 12, 2007
Last Updated:	December 12, 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

ClinicalTrials.gov processed this record on June 23, 2017

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