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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00634855 |
The objective of this study is to determine whether there are alterations in the population of endothelial progenitor cells in umbilical cord blood samples of infants born in the setting of maternal preeclampsia or fetal growth restriction.
Condition |
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Preeclampsia IUGR |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclampsia and IUGR |
Whole blood
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Groups/Cohorts |
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Complicated
Women with pregnancies complicated by intrauterine growth restriction or preeclampsia
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Normal
Women with normal pregnancies
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Preeclampsia remains a significant cause of neonatal and maternal morbidity and mortality. This disorder is found in 5-7% of pregnancies and its incidence is increased in gravid patients with multiple gestations, chronic hypertension, renal disease, autoimmune disease, and at extremes of maternal age. It is responsible for 15% of preterm births which is accompanied by a resultant increase in neonatal morbidity and mortality. In developing countries, it is responsible for approximately 50,000 maternal deaths each year. No widespread intervention to prevent this disease has been found effective and the only effective treatment remains delivery of the fetus.
To date, the cause of preeclampsia is not known although many agree that preeclampsia is a two-stage disease as described by Roberts et al. with the placenta of central importance. The first stage involves poor placental perfusion usually a result of impaired vascular remodeling in early pregnancy or from maternal disease. This leads to the second stage, which is the maternal syndrome of preeclampsia and involves both endothelial and leukocyte activation.
Preeclampsia is associated with an increased maternal cardiovascular risk later in life. Women with a history of preeclampsia demonstrate altered expression of angiogenesis-related proteins and increased insulin resistance as measured by the homeostasis model of insulin resistance. Additionally, preeclampsia is associated with an increase in future cardiovascular risk in the fetus.
Endothelial dysfunction and abnormal regulation of vascular tone that is present in preeclampsia suggests abnormal development of vascular cells such as endothelial progenitor cells. The increased cardiovascular risk of neonates born in the setting of IUGR and preeclampsia also suggests the possibility of abnormal development of endothelial progenitor cells in the fetal compartment in these disease states. The purpose of this pilot project is to determine the effects of preeclampsia/IUGR on endothelial progenitor cells derived from fresh umbilical cord blood.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Pregnant women who are between 30 and 40 weeks gestation and are admitted to MUSC.
Inclusion Criteria:
Gestational age between 30-40 weeks plus:
Preeclampsia by ACOG criteria:
Exclusion Criteria:
Contact: Ashley Ryan, MD | 8437924500 | ryanas@musc.edu |
Contact: Eugene Chang, MD | 8437924500 | changey@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Ashley Ryan, MD | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina ( Ashley Ryan, MD ) |
Study ID Numbers: | HR # 17821 |
Study First Received: | February 19, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00634855 History of Changes |
Health Authority: | United States: Institutional Review Board |
Endothelial progenitor cells Endothelial dysfunction |
Hypertension, Pregnancy-Induced Fetal Diseases Pregnancy Complications Eclampsia Growth Disorders |
Pre-Eclampsia Preeclampsia Fetal Growth Retardation Hypertension |
Hypertension, Pregnancy-Induced Fetal Diseases Pathologic Processes Pregnancy Complications |
Growth Disorders Pre-Eclampsia Fetal Growth Retardation |