Maternal and Fetal Adrenocorticotropic Hormone (ACTH) and Leukemia Inhibitory Factor (LIF) and Gestational Age

NCT03231904 | Unknown

• 1 other identifier: 0508-16-RMB
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In 2010, Simamura et al have demonstrated in a rat model that one of the pro-inflammatory cytokine belonging to the Interleukin-6 family cytokines, LIF, is required for the proliferation of neuronal progenitor cells in the cerebrum. They have shown that maternal LIF induces ACTH from the placenta, which in turn stimulates fetal nucleated red blood cells to secrete LIF, leading finally to neurogenesis in the fetus As demonstrated recently in a mouse model, maternal inflammation suppress the physiological maternal- fetal LIF-ACTH-LIF signal, result in reduction of ACTH production from placenta, which lead to a reduction in LIF concentration in fetal Cerebrospinal fluid (CSF) and impaired proliferation of the neural stem/ progenitor cells and poor development of the fetal brain. In the current study, the investigators will take fetal and maternal blood samples of fetuses undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the routine blood samples before performance of TOP , fetal blood samples will be acquired from the umbilical vessel after the termination has been completed , the blood samples will be analyzed for levels of LIF and ACTH and checked according to termination pregnancy week, Patients electronic files will be checked for relevant demographic and obstetric information.

Conditions

Abortion, Legal

Outcome Measures

Primary Outcomes (4)

• Maternal LIF levels during pregnancy

  Differences in levels of LIF according to gestational age

  up to 6 months

• Maternal ACTH levels during pregnancy

  Differences in levels of ACTH according to gestational age

  up to 6 months

• Fetal LIF levels during pregnancy

  Differences in levels of LIF according to gestational age

  up to 6 months

• Fetal ACTH levels during pregnancy

  Differences in levels of ACTH according to gestational age

  up to 6 months

Interventions

Blood test DIAGNOSTIC_TEST

blood samples will be taken for maternal and fetal levels of ACTH and LIF

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: pregnant women undergoing termination of pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women undergoing termination of pregnancy for different reasons

You may qualify if:

• Pregnant women undergoing termination of pregnancy in various gestational weeks.
• Pregnant women undergoing spontaneous abortion.

You may not qualify if:

• Intrauterine fetal death.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

fetal and maternal blood samples for ACTH and LIF

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yuval Ginsberg, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Ginsberg, MD

CONTACT

0523571199; y_ginsberg@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 27, 2017
• Study Start: August 10, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 31, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share