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Clinical Trials/NCT01883154
NCT01883154
Unknown
Not Applicable

The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome

Meir Medical Center1 site in 1 country160 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Normal Pregnancies
Sponsor
Meir Medical Center
Enrollment
160
Locations
1
Primary Endpoint
Rate of Copy Number Variations
Last Updated
12 years ago

Overview

Brief Summary

Genetic and environmental factors are believed to play a major role in intrauterine growth and intrauterine programming. We intend to study genetic factors such as Telomere homeostasis, senescence, genomic instability and the presence of Genomic copy number variations in placental tissue from pregnancies complicated with Intrauterine growth restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We also intend to assess these factors in cord blood and maternal blood.

Detailed Description

Based on the previous data from our group as well as other laboratories, we postulate that there is a correlation between impaired telomere homeostasis, senescence genomic instability and intra-uterine programming in placentas and in fetuses exposed to suboptimal intrauterine conditions such as hypoxia or hyperglycemia. Improved understanding of the mechanisms that produce the genomic changes in IUGR placentas and their influence on later risks of developing the metabolic syndrome should provide basis for future research that might lead into improved outcome of IUGR fetuses.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2023
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of Intrauterine growth restriction
  • A diagnosis of Gestational diabetes
  • A diagnosis of pre gestational Diabetes
  • IVF pregnancy

Exclusion Criteria

  • chorioamnionitis
  • meconium stained amniotic fluid
  • A request of the patient for Cord blood retrieval for preservation

Outcomes

Primary Outcomes

Rate of Copy Number Variations

Time Frame: 10 yeras

Secondary Outcomes

  • Telomere length(10 years)
  • Number of copies of mitochondrial DNA(10 years)

Study Sites (1)

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