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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02507817
Other study ID # 0604-14-RMB CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 25, 2015
Last updated August 4, 2015
Start date August 2015
Est. completion date June 2017

Study information

Verified date August 2015
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics CommissionIsrael: Israeli Health Ministry Pharmaceutical AdministrationIsrael: Ministry of HealthIsrael: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical Trial Summary

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


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 45 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms

  • LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABOR

Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No