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Status unknownNCT01883154Updated Jun 21, 2013

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

An observational study in Normal Pregnancies, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Meir Medical Center · Observational

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Enrollment
160
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Normal Pregnancies

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03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 160 is below the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • A diagnosis of Intrauterine growth restriction
  • A diagnosis of Gestational diabetes
  • A diagnosis of pre gestational Diabetes
  • IVF pregnancy

Exclusion criteria

Exclusion Criteria:

  • chorioamnionitis
  • meconium stained amniotic fluid
  • A request of the patient for Cord blood retrieval for preservation
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Study design

Enrollment
160 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • IUGR pregnancies

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

  • pregnancies with Gestational Diabetes

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

  • Pre Gestational Diabetes

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

  • IVF pregnancies
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What researchers measure

Primary outcomes

  1. Rate of Copy Number Variations

    Time frame: 10 yeras

Secondary outcomes

  1. Telomere length

    Time frame: 10 years

  2. Number of copies of mitochondrial DNA

    Time frame: 10 years

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Study locations

1 site
  • Meir medical center
    Kfar Saba, Israel
    • Tal Biron Shental, MD · Contact
    • Rivka Sukenik Halevy, MD · Sub investigator
    • Tal Biron Shental, MD · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01883154
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
Jun 21, 2013
Start date
Sep 2013
Primary completion
Sep 2017 (estimated)
Completion
Sep 2023 (estimated)
Last update
Jun 21, 2013

Study contacts

Tal Biron Shental, MD
Contact
Tal.Biron-Shental@clalit.org.il
972-52-836-2331
Rivka Sukenik-Halevy, MD
Contact
riki.sukenik@gmail.com
972-52-6007249

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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