Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications; Preeclampsia; Placental Abruption; Intrauterine Fetal Death; Intrauterine Fetal Growth Restriction

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Avis sourasky medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women who had either normal pregnancy or complicated pregnancy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalenc of elevated factor VIII	RETROSPECTIVE

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Eli Rimon, MD, Tel Aviv medical center,Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Study Completion (Anticipated): January 1, 2008

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 12, 2007
• First Posted (Estimate): December 13, 2007

Study Record Updates

• Last Update Posted (Estimate): December 13, 2007
• Last Update Submitted That Met QC Criteria: December 12, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5).
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Obstetric Labor Complications; Placenta Diseases; Death; Hypertension, Pregnancy-Induced; Growth Disorders; Pre-Eclampsia; Fetal Growth Retardation; Pregnancy Complications; Fetal Death; Stillbirth; Abruptio Placentae
• Other Study ID Numbers: FactorVIII