Correlation Between Vitamin D and B Regulatory Cell in Pregnancy

NCT04105881 | Unknown

• 1 other identifier: Dear
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.

Conditions

Labor, Premature

Outcome Measures

Primary Outcomes (1)

• Changes in number of B regulatory cell in pregnant woman

  Immune system immunosuppressed to maintain fetus

  9 months

Study Arms (3)

Full term labor

Measured by flow cytometry and ELUSA

Dietary Supplement: Investigation

Preterm labor

Measured by flow cytometry and ELISA

Dietary Supplement: Investigation

Control

For comparison

Dietary Supplement: Investigation

Interventions

Investigation DIETARY_SUPPLEMENT

Cross sectional intervention

Control; Full term labor; Preterm labor

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Female Patient should be informed before sampling
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy term delivery women and preterm labor women

You may qualify if:

• healthy female according to the required groups

You may not qualify if:

• patient with infectious disease , tuberculosis ,tumor ,hematologic disease,metabolic bone disease or any other connective tissue diseases were excluded.
• Patient with viral hepatitis.
• serological evidence of HIV infection.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university

Asyut, Asyut Governorate, Egypt

Location

Assiut university

Asyut, Egypt

Location

Related Publications (2)

• Zahran AM, Zharan KM, Hetta HF. Significant correlation between regulatory T cells and vitamin D status in term and preterm labor. J Reprod Immunol. 2018 Sep;129:15-22. doi: 10.1016/j.jri.2018.07.004. Epub 2018 Jul 18.

  PMID: 30029057 RESULT

• Lima J, Martins C, Leandro MJ, Nunes G, Sousa MJ, Branco JC, Borrego LM. Characterization of B cells in healthy pregnant women from late pregnancy to post-partum: a prospective observational study. BMC Pregnancy Childbirth. 2016 Jun 6;16(1):139. doi: 10.1186/s12884-016-0927-7.

  PMID: 27267973 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Total blood and serum

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Contact Tracing

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice

Study Officials

• khalid Hassanein

  Microbiology and immunology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khalid Hassanein, Professor

CONTACT

+20109191208; Khaledhassanein70@aun.edu.eg

Helal Hetta, Lecturer

CONTACT

+201002386255

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: February 10, 2020
• Primary Completion: March 10, 2020
• Study Completion: March 15, 2020
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

EG (2)