Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

The recruitment status of this study is unknown because the information has not been verified recently.
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:


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

Primary Outcome Measures:
  • prevalenc of elevated factor VIII [ Time Frame: RETROSPECTIVE ] [ Designated as safety issue: No ]

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
Genders 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

No publications provided

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
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5).

Additional relevant MeSH terms:
Abruptio Placentae
Hemophilia A
Fetal Death
Fetal Growth Retardation
Pre-Eclampsia
Pregnancy Complications
Obstetric Labor Complications
Placenta Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Death
Pathologic Processes
Fetal Diseases
Growth Disorders
Hypertension, Pregnancy-Induced
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014