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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 : Unknown
Verified June 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Study Description
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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.

Condition or disease
Normal Pregnancies

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 Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Official Title: The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome
Study Start Date : September 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2023

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Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Copy Number Variations [ Time Frame: 10 yeras ]

Secondary Outcome Measures :
  1. Telomere length [ Time Frame: 10 years ]
  2. Number of copies of mitochondrial DNA [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
placental tissue ,fetal cord blood and maternal blood.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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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): NCT01883154


Contacts
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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

Locations
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Israel
Meir medical center
Kfar Saba, Israel
Contact: Tal Biron Shental, MD         
Sub-Investigator: Rivka Sukenik Halevy, MD         
Principal Investigator: Tal Biron Shental, MD         
Sponsors and Collaborators
Meir Medical Center
More Information
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01883154    
Other Study ID Numbers: loe135673ctil
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases