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Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclampsia and IUGR

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ClinicalTrials.gov Identifier: NCT00634855
Recruitment Status : Unknown
Verified March 2008 by Medical University of South Carolina.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2008
Last Update Posted : March 13, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease
Preeclampsia IUGR

Detailed Description:

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.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclampsia and IUGR
Study Start Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Women with pregnancies complicated by intrauterine growth restriction or preeclampsia
Women with normal pregnancies

Outcome Measures

Primary Outcome Measures :
  1. Proportions of endothelial progenitor cells present in umbilical cord [ Time Frame: After birth ]

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women who are between 30 and 40 weeks gestation and are admitted to MUSC.

Inclusion Criteria:

  • Pregnant women 18-45
  • Gestational age between 30-40 weeks plus:

    • Uncomplicated pregnancy or
    • Fetal estimated weight <10% for gestational age or abdominal circumference <5% or
    • Preeclampsia by ACOG criteria:

      1. HTN > 140/90 on two occasions
      2. Proteinuria > 300mg on 24 hour urine specimen or 1+ on urine dip

Exclusion Criteria:

  • Non-reassuring fetal status
  • Congenital abnormalities
  • Multiple gestations
  • Clinical Chorioamnionitis
  • Recent infectious disease (within 2 weeks)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634855

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 Not yet recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Ashley Ryan, MD         
Sponsors and Collaborators
Medical University of South Carolina
Principal Investigator: Ashley Ryan, MD Medical University of South Carolina
More Information

Responsible Party: Ashley Ryan, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00634855     History of Changes
Other Study ID Numbers: HR # 17821
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by Medical University of South Carolina:
Endothelial progenitor cells
Endothelial dysfunction

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications