LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABORNCT02507817
Correlation Between LIF (Leukemia Inhibitory Factor ) Levels in Cord and Maternal Blood in Women Treated With Mg
An observational study of LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABOR, run by Rambam Health Care Campus.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABOR
- What is being tested?
- blood sample and tissue sample
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Women in 31-32 weeks gestation that where treated with Magnesium Sulphate for neuroprotection.
- Women in 33-34 weeks gestation that per protocol are not entitled for treatment with Magnesium Sulphate for neuroprotection.
- Women that had severe preeclampsia and where treated with Magnesium Sulphate for seizure prophylaxis and delivered after 34 weeks of gestation.
- Low risk pregnancies in similar weeks to group 3 that did not require any special treatment and delivered after 34 weeks of gestation
Who cannot join
- Women who do not agree known genetic diseases or fetal abnormality
About this study
Official title: 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.
Read more
Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the embryo's brain in one of two ways:
- Altering Placental ACTH
- 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
Read the 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:
- Altering Placental ACTH
- 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 .
- Being tested
- blood sample and tissue sample
- Keywords
- LIF,Magnesium Sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample and tissue sampleOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: blood sample and tissue sample | |
| 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). Receives: Other: blood sample and tissue sample | |
| 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). Receives: Other: blood sample and tissue sample | |
| 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). Receives: Other: blood sample and tissue sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABORStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507817
- Sponsor's protocol ID
- 0604-14-RMB CTIL
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between LIF Levels in Cord Blood to Maternal Blood in Women Treated With Mg During Labor
- ClinicalTrials.gov ID
- NCT02507817
- Acronym / sponsor ID
- 0604-14-RMB CTIL
- Keywords
- LIF,Magnesium Sulphate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Altering Placental ACTH
- 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
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:
- Altering Placental ACTH
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 31-32 with Mg for neuroprotection | – | Other: blood sample and tissue sampleWomen in 31-32 weeks gestation that where treated with Magnesium Sulphate for neuroprotection. blood sample and tissue sample (placenta). |
| 33-34 without Mg for neuroprotection | – | Other: blood sample and tissue sampleWomen in 33-34 weeks gestation that per protocol are not entitled for treatment with Magnesium Sulphate for neuroprotection. blood sample and tissue sample (placenta). |
| PET with Mg after 34 weeks | – | Other: blood sample and tissue sampleWomen 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). |
| control | – | Other: blood sample and tissue sampleLow 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). |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- Women in 31-32 weeks gestation that where treated with Magnesium Sulphate for neuroprotection.
- Women in 33-34 weeks gestation that per protocol are not entitled for treatment with Magnesium Sulphate for neuroprotection.
- Women that had severe preeclampsia and where treated with Magnesium Sulphate for seizure prophylaxis and delivered after 34 weeks of gestation.
- Low risk pregnancies in similar weeks to group 3 that did not require any special treatment and delivered after 34 weeks of gestation
Key exclusion criteria (1 listed)
- Women who do not agree known genetic diseases or fetal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample and tissue sampleMaternal 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 | Other | 31-32 with Mg for neuroprotection, 33-34 without Mg for neuroprotection, PET with Mg after 34 weeks, control |
Primary outcome
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)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of LIF LEVELS IN CORD BLOOD AND MATERNAL BLOOD DURING LABOR, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.