Status:
COMPLETED
Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
POM Wonderful LLC
University of California, Los Angeles
Conditions:
Intrauterine Growth Restriction
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Infants with intrauterine growth restriction are known to be at increased risk for long term neurodevelopmental delay into adulthood. The main mechanism for this is likely decreased blood flow to the ...
Detailed Description
This study is divided into two separate phases. Phase I evaluated if the antioxidants produced from pomegranate juice cross the placenta in normal healthy pregnancies. Twenty women were enrolled, 10 ...
Eligibility Criteria
Inclusion
- Phase I:
- Healthy expecting mothers two weeks from their expected due dates
- No evidence of IUGR
- No evidence of fetal problems
- Phase II:
- Expecting mother with a fetal diagnosis of intrauterine growth restriction (IUGR) defined by estimated fetal weight \<10th percentile for gestational age
- 24 - 34 weeks gestation
Exclusion
- Major congenital abnormalities
- Known fetal chromosomal disorder
- Maternal illicit drug use
- Maternal IV and Hepatitis C infection
- Premature rupture of membranes
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00788866
Start Date
December 1 2008
End Date
October 1 2014
Last Update
October 17 2014
Active Locations (1)
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1
St Louis Children's Hospital
St Louis, Missouri, United States, 63110