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

Normal Pregnancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01883154
• Other study ID #: loe135673ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2013
• Last updated: June 19, 2013
• Start date: September 2013
• Est. completion date: September 2023

Study information

• Verified date: June 2013
• Source: Meir Medical Center
• Contact: Tal Biron Shental, MD
• Phone: 972-52-836-2331
• Email: Tal.Biron-Shental[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: September 2023
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Normal Pregnancies

Locations

Country	Name	City	State
Israel	Meir medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Copy Number Variations		10 yeras	No
Secondary	Telomere length		10 years	No
Secondary	Number of copies of mitochondrial DNA		10 years	No