This trial is active, not recruiting.

Conditions pregnancy complications, preeclampsia, placental abruption, intrauterine fetal growth restriction, intrauterine fetal death
Sponsor Tel-Aviv Sourasky Medical Center
Start date January 2000
End date January 2008
Trial size 100 participants
Trial identifier NCT00573118, FactorVIII


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
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).
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

Primary Outcomes

prevalenc of elevated factor VIII

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title A Retrospective Analysis of Possible Association Between Severe Pregnancy Complications and Elevated Factor VIII Plasma Activity.
Principal investigator Eli Rimon, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center.