Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

NCT ID: NCT00573118

Last Updated: 2007-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv medical center; Israel

Principal Investigators

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Eli Rimon, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv medical center,Israel

Locations

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Tel Avis sourasky medical center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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FactorVIII

Identifier Type: -

Identifier Source: org_study_id