Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

Preeclampsia Clinical Trial

Official title:

A Retrospective Analysis of Possible Association Between Severe Pregnancy Complications and Elevated Factor VIII Plasma Activity.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00573118
• Other study ID #: FactorVIII
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2007
• Last updated: December 12, 2007
• Start date: January 2000
• Est. completion date: January 2008

Study information

• Verified date: December 2007
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abruptio Placentae
• Fetal Death
• Fetal Growth Retardation
• Intrauterine Fetal Death
• Intrauterine Fetal Growth Restriction
• Placental Abruption
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

Locations

Country	Name	City	State
Israel	Tel Avis sourasky medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalenc of elevated factor VIII		RETROSPECTIVE	No