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

NCT ID: NCT01883154

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Normal Pregnancies

Study Groups

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IUGR pregnancies

Pregnancies complicated with IUGR. Fetal growth beneath the 10th percentile

No interventions assigned to this group

pregnancies with Gestational Diabetes

Normal glucose levels before 20 weeks, and positive Oral glucose tolerance test

No interventions assigned to this group

Pre Gestational Diabetes

A diagnosis of Diabetes before pregnancy or elevated glucose levels before 20 weeks.

No interventions assigned to this group

IVF pregnancies

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir medical center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Tal Biron Shental, MD

Role: CONTACT

972-52-836-2331

Rivka Sukenik-Halevy, MD

Role: CONTACT

972-52-6007249

Facility Contacts

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Tal Biron Shental, MD

Role: primary

Other Identifiers

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loe135673ctil

Identifier Type: -

Identifier Source: org_study_id

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