NCT00634855

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

4 years

First QC Date

February 19, 2008

Last Update Submit

June 13, 2018

Conditions

PreeclampsiaIUGR

Keywords

Endothelial progenitor cellsEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Proportions of endothelial progenitor cells present in umbilical cord

    After birth

Study Arms (2)

Complicated

Women with pregnancies complicated by intrauterine growth restriction or preeclampsia

Normal

Women with normal pregnancies

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women who are between 30 and 40 weeks gestation and are admitted to MUSC.

You may qualify if:

  • 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:
  • HTN \> 140/90 on two occasions
  • Proteinuria \> 300mg on 24 hour urine specimen or 1+ on urine dip

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ashley Ryan, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

March 13, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

US(1)