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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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Clalit Health Services

Status

Unknown

Conditions

Normal Pregnancies

Study type

Observational

Funder types

Other

Identifiers

NCT01883154
loe135673ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

160 participants in 4 patient groups

IUGR pregnancies
Description:
Pregnancies complicated with IUGR. Fetal growth beneath the 10th percentile
pregnancies with Gestational Diabetes
Description:
Normal glucose levels before 20 weeks, and positive Oral glucose tolerance test
Pre Gestational Diabetes
Description:
A diagnosis of Diabetes before pregnancy or elevated glucose levels before 20 weeks.
IVF pregnancies

Trial contacts and locations

1

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Central trial contact

Tal Biron Shental, MD; Rivka Sukenik-Halevy, MD

Data sourced from clinicaltrials.gov

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