Correlation Between LIF (Leukemia Inhibitory Factor ) Levels in Cord and Maternal Blood in Women Treated With Mg

The Correlation Between LIF Levels in Cord Blood to Maternal Blood in Women Treated With Mg During Labor

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 (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

Study Overview

• Status: Unknown
• Conditions: LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABOR
• Intervention / Treatment: Other: blood sample and tissue sample

Detailed Description

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 (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 .

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

1. Women in 31-32 weeks gestation that where treated with Magnesium Sulphate for neuroprotection.
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 pregnanacies in similar weeks to group 3 that did not require any special teatment and delivered after 34 weeks of gestation

Description

Inclusion Criteria:

1. Women in 31-32 weeks gestation that where treated with Magnesium Sulphate for neuroprotection.
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:

- Women who do not agree known genetic diseases or fetal abnormality

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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).	Other: 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).	Other: 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).	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between LIF Levels in women who where treated with Mg and women who where not (maternal LIF levels prior to birth and Maternal and cord levels after delivery)	2 years

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: LIF,Magnesium Sulphate
• Other Study ID Numbers: 0604-14-RMB CTIL