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

• Conditions: Normal Pregnancies

• Registration Number: NCT01883154
• Lead Sponsor: Meir Medical Center

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 Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Study First Posted: 2013-06-21
• Last Update Posted: 2013-06-21
• Study Start: 2013-09
• Primary Completion: 2017-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Copy Number Variations	10 yeras

Secondary Outcome Measures

Name	Time	Method
Telomere length	10 years
Number of copies of mitochondrial DNA	10 years

Trial Locations

Locations (1)

Meir medical center; 🇮🇱 Kfar Saba, Israel