Clinical trial NCT03231904: Maternal and Fetal Adrenocorticotropic Hormone (ACTH) and Leukemia Inhibitory Factor (LIF) and Gestational Age
Official title: The Correlation Between Gestational Age and Maternal and Fetal Levels of LIF and ACTH
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abortion, Legal
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women undergoing termination of pregnancy for different reasons

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

•Intrauterine fetal death.

Primary outcomes:
measure: Maternal LIF levels during pregnancy
timeFrame: up to 6 months
measure: Maternal ACTH levels during pregnancy
timeFrame: up to 6 months
measure: Fetal LIF levels during pregnancy
timeFrame: up to 6 months
measure: Fetal ACTH levels during pregnancy
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Yuval Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: