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

Abortion, Legal Clinical Trial

Official title:

The Correlation Between Gestational Age and Maternal and Fetal Levels of LIF and ACTH

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03231904
• Other study ID #: 0508-16-RMB
• Status: Not yet recruiting
• Phase: N/A
• First received: July 1, 2017
• Last updated: August 3, 2017
• Start date: August 10, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2017
• Source: Rambam Health Care Campus
• Contact: Yuval Ginsberg, MD
• Phone: 0523571199
• Email: y_ginsberg[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study protocol:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

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

• Pregnant women undergoing spontaneous abortion.

Exclusion Criteria:

•Intrauterine fetal death.

Related Conditions & MeSH terms

• Abortion, Legal

Intervention

Diagnostic Test:
• Blood test
blood samples will be taken for maternal and fetal levels of ACTH and LIF

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	Maternal LIF levels during pregnancy	Differences in levels of LIF according to gestational age	up to 6 months
Primary	Maternal ACTH levels during pregnancy	Differences in levels of ACTH according to gestational age	up to 6 months
Primary	Fetal LIF levels during pregnancy	Differences in levels of LIF according to gestational age	up to 6 months
Primary	Fetal ACTH levels during pregnancy	Differences in levels of ACTH according to gestational age	up to 6 months