Clincosm LogoSign in Get a demo

Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00573118
Collaborator
(none)
100
Enrollment
1
Location
96
Duration (Months)
1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2000
    Anticipated Study Completion Date :
    Jan 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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

    1. prevalenc of elevated factor VIII [RETROSPECTIVE]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00573118
    Other Study ID Numbers:
    • FactorVIII
    First Posted:
    Dec 13, 2007
    Last Update Posted:
    Dec 13, 2007
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5).
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Pregnancy Complications
    Fetal Growth Retardation
    Fetal Death
    Abruptio Placentae
    Stillbirth

    Study Results

    No Results Posted as of Dec 13, 2007