Correlation Between LIF (Leukemia Inhibitory Factor ) Levels in Cord and Maternal Blood in Women Treated With Mg
NCT ID: NCT02507817
Last Updated: 2015-08-07
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2015-08-31
2017-06-30
Brief Summary
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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 (adrenocorticotropic hormone) that in turn promotes secretion of fetal LIF from nRBC (nucleated red blood cell ), which in turn promotes brain development of the fetus In other studies on rats a theory was proposed that LPS (lipopolysaccharide) and infection during pregnancy influence the normal development of the brain and may cause brain damage by altering placental ACTH thank in turn alters LIF secretion in the embryo which could be the cause of brain damage.
Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the embryo's brain in one of two ways:
1. Altering Placental ACTH
2. Altering the number of receptors for LIF in the brain Women who are at risk for preterm labor prior to 32 weeks of gestation are treated with Magnesium Sulphate for neuroprotection, randomized controlled studies showed that if these women are treated in the 24 hours prior to labor with magnesium sulphate the risk for cerebral palsy and other severe motor problems are decreased.
The mechanism for this decrease is unknown and that is the purpose of our study.
The purpose of our research is to examine maternal LIF levels prior to birth and Maternal and cord levels after delivery and to see if levels are different if the mother was treated with Magnesium Sulphate. We will also check the placental ACTH level
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Detailed Description
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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 (adrenocorticotropic hormone) that in turn promotes secretion of fetal LIF from nRBC (nucleated red blood cell ), which in turn promotes brain development of the fetus In other studies on rats a theory was proposed that LPS (lipopolysaccharide) and infection during pregnancy influence the normal development of the brain and may cause brain damage by altering placental ACTH thank in turn alters LIF secretion in the embryo which could be the cause of brain damage.
Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the embryo's brain in one of two ways:
1. Altering Placental ACTH
2. Altering the number of receptors for LIF in the brain Women who are at risk for preterm labor prior to 32 weeks of gestation are treated with Magnesium Sulphate for neuroprotection, randomized controlled studies showed that if these women are treated in the 24 hours prior to labor with magnesium sulphate the risk for cerebral palsy and other severe motor problems are decreased.
The mechanism for this decrease is unknown and that is the purpose of our study.
The purpose of our research is to examine maternal LIF levels prior to birth and Maternal and cord levels after delivery and to see if levels are different if the mother was treated with Magnesium Sulphate. We will also check the placental ACTH level .
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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31-32 with Mg for neuroprotection
Women in 31-32 weeks gestation that where treated with Magnesium Sulphate for neuroprotection.
blood sample and tissue sample (placenta).
blood sample and tissue sample
Maternal LIF levels prior and after delivery.After birth and disconnection of the cord, we also will take a blood sample from the umbilical cord (5cc) for cytokine ELISA testing.
A small sample of the placenta will be examined in order to assess the level of ACTH protein
33-34 without Mg for neuroprotection
Women in 33-34 weeks gestation that per protocol are not entitled for treatment with Magnesium Sulphate for neuroprotection.
blood sample and tissue sample (placenta).
blood sample and tissue sample
Maternal LIF levels prior and after delivery.After birth and disconnection of the cord, we also will take a blood sample from the umbilical cord (5cc) for cytokine ELISA testing.
A small sample of the placenta will be examined in order to assess the level of ACTH protein
PET with Mg after 34 weeks
Women that had severe preeclamsia and where treated with Magnesium Sulphate for seizure prophylaxis and delivere after 34 weeks of gestation.
blood sample and tissue sample (placenta).
blood sample and tissue sample
Maternal LIF levels prior and after delivery.After birth and disconnection of the cord, we also will take a blood sample from the umbilical cord (5cc) for cytokine ELISA testing.
A small sample of the placenta will be examined in order to assess the level of ACTH protein
control
Low risk pregnanacies in similar weeks to group 3 that did not require any special teatment and delivered after 34 weeks of gestation.
blood sample and tissue sample (placenta).
blood sample and tissue sample
Maternal LIF levels prior and after delivery.After birth and disconnection of the cord, we also will take a blood sample from the umbilical cord (5cc) for cytokine ELISA testing.
A small sample of the placenta will be examined in order to assess the level of ACTH protein
Interventions
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blood sample and tissue sample
Maternal LIF levels prior and after delivery.After birth and disconnection of the cord, we also will take a blood sample from the umbilical cord (5cc) for cytokine ELISA testing.
A small sample of the placenta will be examined in order to assess the level of ACTH protein
Eligibility Criteria
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Inclusion Criteria
2. Women in 33-34 weeks gestation that per protocol are not entitled for treatment with Magnesium Sulphate for neuroprotection.
3. Women that had severe preeclampsia and where treated with Magnesium Sulphate for seizure prophylaxis and delivered after 34 weeks of gestation.
4. Low risk pregnancies in similar weeks to group 3 that did not require any special treatment and delivered after 34 weeks of gestation
Exclusion Criteria
16 Years
45 Years
FEMALE
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Other Identifiers
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0604-14-RMB CTIL
Identifier Type: -
Identifier Source: org_study_id
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