Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
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Pregnancy Complications Preeclampsia Placental Abruption Intrauterine Fetal Growth Restriction Intrauterine Fetal Death |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | A Retrospective Analysis of Possible Association Between Severe Pregnancy Complications and Elevated Factor VIII Plasma Activity. |
- prevalenc of elevated factor VIII [ Time Frame: RETROSPECTIVE ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | January 2008 |
| Groups/Cohorts |
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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).
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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
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Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00573118
| Israel | |
| Tel Avis sourasky medical center | |
| Tel Aviv, Israel, 64239 | |
| Principal Investigator: | Eli Rimon, MD | Tel Aviv medical center,Israel |
More Information
| Responsible Party: | Eli Rimon,MD, Tel Aviv medical center; Israel |
| ClinicalTrials.gov Identifier: | NCT00573118 History of Changes |
| Other Study ID Numbers: | FactorVIII |
| Study First Received: | December 12, 2007 |
| Last Updated: | December 12, 2007 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Tel-Aviv Sourasky Medical Center:
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Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5). |
Additional relevant MeSH terms:
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Pre-Eclampsia Hemophilia A Pregnancy Complications Fetal Growth Retardation Fetal Death Stillbirth Abruptio Placentae Hypertension, Pregnancy-Induced Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Fetal Diseases Growth Disorders Pathologic Processes Death Obstetric Labor Complications Placenta Diseases Factor VIII Coagulants |
ClinicalTrials.gov processed this record on September 27, 2016