Working… Menu

Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Tel-Aviv Sourasky Medical Center

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

Layout table for study information
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

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).
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

Primary Outcome Measures :
  1. prevalenc of elevated factor VIII [ Time Frame: RETROSPECTIVE ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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

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 identifier (NCT number): NCT00573118

Layout table for location information
Tel Avis sourasky medical center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Layout table for investigator information
Principal Investigator: Eli Rimon, MD Tel Aviv medical center,Israel

Layout table for additonal information
Responsible Party: Eli Rimon,MD, Tel Aviv medical center; Israel 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:
Layout table for MeSH terms
Pregnancy Complications
Fetal Growth Retardation
Fetal Death
Abruptio Placentae
Hypertension, Pregnancy-Induced
Fetal Diseases
Growth Disorders
Pathologic Processes
Obstetric Labor Complications
Placenta Diseases
Factor VIII