CClinicalTrials.gg
Status unknownNCT03231904Updated Aug 4, 2017

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

An observational study in Abortion, Legal, sponsored by Rambam Health Care Campus. Status unknown. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Rambam Health Care Campus · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Abortion, Legal
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women undergoing termination of pregnancy for different reasons

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

•Intrauterine fetal death.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testBlood test

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

06

What researchers measure

Primary outcomes

  1. Maternal LIF levels during pregnancy

    Differences in levels of LIF according to gestational age

    Time frame: up to 6 months

  2. Maternal ACTH levels during pregnancy

    Differences in levels of ACTH according to gestational age

    Time frame: up to 6 months

  3. Fetal LIF levels during pregnancy

    Differences in levels of LIF according to gestational age

    Time frame: up to 6 months

  4. Fetal ACTH levels during pregnancy

    Differences in levels of ACTH according to gestational age

    Time frame: up to 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03231904
Lead sponsor
Rambam Health Care Campus
Responsible party
Yuval Ginsberg, MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Jul 27, 2017
Start date
Aug 10, 2017 (estimated)
Primary completion
Nov 30, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Aug 4, 2017

Study contacts

Yuval Ginsberg, MD
Contact
y_ginsberg@rambam.health.gov.il
0523571199
Yuval Ginsberg, MD
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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