CClinicalTrials.gg
Status unknownNCT04105881Updated Sep 26, 2019

Correlation Between Vitamin D and B Regulatory Cell in Pregnancy

An observational study in Labor, Premature, sponsored by Assiut University. Status unknown at 2 sites in Egypt. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
20 Years to 50 Years
Sex
Female
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Study 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.

Read the detailed description

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.the fetus is normally accepted by the maternal immune system despite despite the expression of paternal alloantigens. Normally, the fetus grows and develops very well with ongoing pregnancy.

B regulatory cells are increased in pregnant women compared to non-pregnant women.

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Conditions studied

  • Labor, Premature
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In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

This study's planned enrollment of 90 is below the median of 125 across 85 observational studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy term delivery women and preterm labor women

Inclusion criteria

  • healthy female according to the required groups

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Dietary supplementInvestigation

    Cross sectional intervention

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What researchers measure

Primary outcomes

  1. Changes in number of B regulatory cell in pregnant woman

    Immune system immunosuppressed to maintain fetus

    Time frame: 9 months

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Study locations

2 sites
  • Assiut university
    Asyut, Assiut, Egypt
    • Khalid Hassanein, Professor · Contact · +201091912080
    • Helal Hetta, Lecturer · Contact · +201002386255
  • Assiut university
    Assiut, Egypt
    • Khalid Hassanein, Professor · Contact · 01091912080
    • Helal Hetta · Contact · 01002386255
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References and documents

Publications

  • 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. PubMed 30029057 ↗
  • 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. PubMed 27267973 ↗

Individual participant data

Plan to share: Undecided — Role of immune system in maintenance of pregnancy

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04105881
Lead sponsor
Assiut University
Responsible party
Haitham Mohamed Sedky (Principle investigator, Assiut University) — Principal investigator
First posted
Sep 26, 2019
Start date
Feb 10, 2020 (estimated)
Primary completion
Mar 10, 2020 (estimated)
Completion
Mar 15, 2020 (estimated)
Last update
Sep 26, 2019

Study contacts

Khalid Hassanein, Professor
Contact
Khaledhassanein70@aun.edu.eg
+20109191208
Helal Hetta, Lecturer
Contact
+201002386255
khalid Hassanein
principal investigator · Microbiology and immunology department
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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