## Protocol Section
### Identification Module
**NCT ID:** NCT01081379

**Brief Title:** The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

**Official Title:** The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

#### Organization Study ID Info
**ID:** Schlesinger - CMV
#### Organization
**Class:** OTHER
**Full Name:** Shaare Zedek Medical Center
### Status Module
#### Completion Date
**Date:** 2022-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-11-13

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-02

**Type:** ACTUAL

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2010-03-05
**Type:** ESTIMATED
**Study First Submit Date:** 2010-03-04
**Study First Submit QC Date:** 2010-03-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shaare Zedek Medical Center

#### Responsible Party

**Investigator Affiliation:** Shaare Zedek Medical Center

**Investigator Full Name:** Yedidia Yifat

**Investigator Title:** Yechiel Schlesinger, MD, Shaare Zedek Medical Center.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

**Detailed Description:** Fetal infection with CMV is the most common cause of intrauterine infection. Only 40% of pregnant women with primary CMV transmit the virus to their fetus. Many of these women are referred to amniocentesis and many elect to terminate pregnancy without knowledge about fetal infection or damage. Currently it is assumed that transmission is dictated by variety of factors including maternal and fetal immune system. Efforts to find correlation between maternal immune system and fetal infection which can be used as a diagnostic marker were unsuccessful.

Our hypothesis is that there is a correlation between cellular immune response of the mother to CMV infection and viral transmission to the fetus.

Pregnant women with primary CMV infection (40% of whom are expected to be transmitters)and with pre-conception immunity will participate in this study.

Blood from these women will be incubated with CMV peptides and T cell activation will be measured by the secretion of various cytokines.

### Conditions Module

**Conditions:**

- Pregnant Women

- Cytomegalovirus Infections

**Keywords:**

- Cytomegalovirus Infections

- Pregnancy

- T-Lymphocytes

- Transmission

### Design Module

#### Bio Spec

**Description:** serum

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** pre-conception immunity- pregnant women with CMV seropositive

**Label:** pre-conception immunity

#### Arm Group 2

**Description:** primary CMV infection- pregnant women with primary CMV infection (defined as CMV IgG sero-conversion, the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies).

**Label:** primary CMV infection

### Outcomes Module

#### Primary Outcomes

**Measure:** Maternal-Fetal transmission of CMV

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant women
* CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies.

Exclusion Criteria:

* Underlying immune deficiencies
* Other pregnancy complications

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Pregnant women with primary CMV

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** s.yechiel@gmail.com

**Name:** Yechiel Schlesinger, M.D.

**Phone:** 972-2-6555-147

**Role:** CONTACT

**Contact 2:**

**Email:** yifat4@gmail.com

**Name:** Yifat Yedidia-Eldar, Ph. D.

**Phone:** 972-26666-775

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jerusalem

**Contacts:**

***Contact 1:***

- **Name:** Yechiel Schlesinger, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Israel

**Facility:** Shaare Zedek Medical Center

**Status:** RECRUITING

**Zip:** 91031

#### Overall Officials

**Official 1:**

**Affiliation:** Shaare Zedek Medical Center

**Name:** Yechiel Schlesinger, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006566

- Term: Herpesviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M6791

- Name: Cytomegalovirus Infections

- Relevance: HIGH

- As Found: Cytomegalovirus Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M9643

- Name: Herpesviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T1720

- Name: Cytomegalic Inclusion Disease

- Relevance: HIGH

- As Found: Cytomegalovirus Infections

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000003586

- Term: Cytomegalovirus Infections

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M10122

- Name: Immunoglobulin G

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
