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

Primary Purpose

Normal Pregnancies

Status

Unknown status

Phase

Locations

Israel

Study Type

Observational

Intervention

About this trial

This is an observational trial for Normal Pregnancies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Meir medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Arm Label

IUGR pregnancies

pregnancies with Gestational Diabetes

Pre Gestational Diabetes

IVF pregnancies

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Rate of Copy Number Variations

Secondary Outcome Measures

Telomere length

Number of copies of mitochondrial DNA

Full Information

NCT ID

NCT01883154

First Posted

June 11, 2013

Last Updated

June 19, 2013

Sponsor

Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01883154

Brief Title

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

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meir Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Normal Pregnancies

7. Study Design

Enrollment

160 (Anticipated)

Biospecimen Retention

Samples With DNA

Biospecimen Description

placental tissue ,fetal cord blood and maternal blood.

8. Arms, Groups, and Interventions

Arm Title

IUGR pregnancies

Arm Description

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

Arm Title

pregnancies with Gestational Diabetes

Arm Description

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

Arm Title

Pre Gestational Diabetes

Arm Description

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

Arm Title

IVF pregnancies

Primary Outcome Measure Information:

Title

Rate of Copy Number Variations

Time Frame

10 yeras

Secondary Outcome Measure Information:

Title

Telomere length

Time Frame

10 years

Title

Number of copies of mitochondrial DNA

Time Frame

10 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Study Population Description

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.

Sampling Method

Non-Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tal Biron Shental, MD

Phone

972-52-836-2331

Tal.Biron-Shental@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Rivka Sukenik-Halevy, MD

Phone

972-52-6007249

riki.sukenik@gmail.com

Facility Information:

Facility Name

Meir medical center

City

Kfar Saba

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tal Biron Shental, MD

First Name & Middle Initial & Last Name & Degree

Rivka Sukenik Halevy, MD

First Name & Middle Initial & Last Name & Degree

Tal Biron Shental, MD

12. IPD Sharing Statement

Learn more about this trial

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

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