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

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ClinicalTrials.gov Identifier: NCT01883154
Recruitment Status : Not yet recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date June 11, 2013
First Posted Date June 21, 2013
Last Update Posted Date June 21, 2013
Study Start Date September 2013
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2013)
Rate of Copy Number Variations [ Time Frame: 10 yeras ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 19, 2013)
  • Telomere length [ Time Frame: 10 years ]
  • Number of copies of mitochondrial DNA [ Time Frame: 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome
Official Title The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
placental tissue ,fetal cord blood and maternal blood.
Sampling Method Non-Probability Sample
Study Population Samples from pregnancies complicated with IUGR, Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We intend to assess these factors in placental tissue, in cord blood and maternal blood.
Condition Normal Pregnancies
Intervention Not Provided
Study Groups/Cohorts
  • IUGR pregnancies
    Pregnancies complicated with IUGR. Fetal growth beneath the 10th percentile
  • pregnancies with Gestational Diabetes
    Normal glucose levels before 20 weeks, and positive Oral glucose tolerance test
  • Pre Gestational Diabetes
    A diagnosis of Diabetes before pregnancy or elevated glucose levels before 20 weeks.
  • IVF pregnancies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 19, 2013)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Tal Biron Shental, MD 972-52-836-2331 Tal.Biron-Shental@clalit.org.il
Contact: Rivka Sukenik-Halevy, MD 972-52-6007249 riki.sukenik@gmail.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01883154
Other Study ID Numbers loe135673ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date June 2013