Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates

NCT ID: NCT02518126

Last Updated: 2015-08-07

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-06-30

Brief Summary

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To see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses

Detailed Description

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During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin 1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with neurogenesis and differentiation of brain cells .

LIF is a cytokine that is essential for the development of the central nervous system, and has recently been shown in rats that maternal LIF stimulates placental ACTH that in turn promotes secretion of fetal LIF from nRBC , which in turn promotes brain development of the fetus Other studies on IUGR (Intra Uterine Growth Restriction) have shown that IUGR fetuses have more CP (Cerebral palsy) than those who were AGA (Average for Gestational Age) The hypothesis is that LIF is related to the proper development of the nervous system in the fetus and by testing cord blood of embryos IUGR and the placenta we will find changes in LIF and ACTH compared with AGA fetuses level.

Studies have also shown a relationship between CP and IUGR, but the mechanism for this relationship is unclear.

The purpose of our research is to see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses, in one of two ways:

* Changes in the secretion of ACTH in placenta
* Changes in levels of LIF in the umbilical cord blood

Conditions

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to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

Women with IUGR embryos so that their fetal weight estimate puts them in a percentile bellow 10th percentile

blood sample and tissue sample

Intervention Type OTHER

After birth and fetal umbilical cord disconnection, a blood sample will be taken from the umbilical cord (cord blood) of IUGR and of AGA fetuses (5cc) for cytokine ELISA testing. Also a small sample of the placenta will be examined in order to assess the level of ACTH protein in IUGR and AGA embryos

IUGR

Women with AGA embryos so that their fetal weight estimate puts them in a percentile between 20th and 80th percentiles

blood sample and tissue sample

Intervention Type OTHER

After birth and fetal umbilical cord disconnection, a blood sample will be taken from the umbilical cord (cord blood) of IUGR and of AGA fetuses (5cc) for cytokine ELISA testing. Also a small sample of the placenta will be examined in order to assess the level of ACTH protein in IUGR and AGA embryos

Interventions

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blood sample and tissue sample

After birth and fetal umbilical cord disconnection, a blood sample will be taken from the umbilical cord (cord blood) of IUGR and of AGA fetuses (5cc) for cytokine ELISA testing. Also a small sample of the placenta will be examined in order to assess the level of ACTH protein in IUGR and AGA embryos

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women that the Fetal weight estimate puts the fetus bellow the 10th percentile and those that the fetal weight estimate are between 20th and 80th percentiles

Exclusion Criteria

* Women who do not agree
* known Genetic diseases of abnormalities in the fetus
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0176-15-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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