Maternal and Fetal Adrenocorticotropic Hormone (ACTH) and... | NCT03231904

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

NCT03231904

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Aug 4, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Abortion, Legal

Interventions

Blood test

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2017Estimated

Primary Completion Date

Nov 30, 2017Estimated

Completion Date

Dec 31, 2017Estimated

First Submitted Date

Jul 1, 2017

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2017

Last Update Posted Date

Aug 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuval Ginsberg, MD, Principal Investigator, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Diagnostic Test	blood samples will be taken for maternal and fetal levels of ACTH and LIF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

•Intrauterine fetal death.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women undergoing termination of pregnancy

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Pregnant women undergoing termination of pregnancy for different reasons

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuval Ginsberg, MD	Contact	0523571199		y_ginsberg@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Yuval Ginsberg, MD	Rambam Health Care Campus	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

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Browse Branches

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