Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

NCT00573118 | Unknown

• 1 other identifier: FactorVIII
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• prevalenc of elevated factor VIII

  RETROSPECTIVE

Study Arms (2)

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 Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women who had either normal pregnancy or complicated pregnancy

You may qualify if:

• Women who had either normal pregnancy or complicated pregnancy.

You may not qualify if:

• Other causes of pregnancy complication such as infections, anomalies and fetal malformations

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Avis sourasky medical center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Pregnancy Complications; Pre-Eclampsia; Abruptio Placentae; Stillbirth; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Obstetric Labor Complications; Placenta Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders

Study Officials

• Eli Rimon, MD

  Tel Aviv medical center,Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2000
• Study Completion: January 1, 2008
• Last Updated: December 13, 2007

Record last verified: 2007-12

Locations

IL (1)