Labor, PrematureNCT04105881
Correlation Between Vitamin D and B Regulatory Cell in Pregnancy
An observational study of Labor, Premature, run by Assiut University at 2 sites in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Premature
- What is being tested?
- Investigation
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Feb 2020to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy term delivery women and preterm labor women
Who may be able to join
- healthy female according to the required groups
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Helal Hetta, Lecturer contact
Egypt2 sites
Assiut university
Asyut, Asyut Governorate
Khalid Hassanein, Professor, +201091912080
Helal Hetta, Lecturer, +201002386255
Assiut university
Asyut
Khalid Hassanein, Professor, 01091912080
Helal Hetta, 01002386255
About this study
Official title: Correlation Between B Regulatory Cell and Vitamin D Status in Term and Preterm Labor
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.
- Conditions
- Labor, Premature
- Being tested
- Investigation
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvestigationDietary supplement
Cross sectional intervention
| Study group | Role | What they receive |
|---|---|---|
| Full term labor | Measured by flow cytometry and ELUSA Receives: Dietary Supplement: Investigation | |
| Preterm labor | Measured by flow cytometry and ELISA Receives: Dietary Supplement: Investigation | |
| Control | For comparison Receives: Dietary Supplement: Investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in number of B regulatory cell in pregnant woman
Immune system immunosuppressed to maintain fetus
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Feb 2020 (estimated)
- Primary completion10 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor, PrematureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mohamed Sedky, Assiut University
- Investigators
- khalid Hassanein, Principal investigator, Microbiology and immunology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105881
- Sponsor's protocol ID
- Dear
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Individual data sharing
- Undecided: Role of immune system in maintenance of pregnancy
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 30029057Lima 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between B Regulatory Cell and Vitamin D Status in Term and Preterm Labor
- ClinicalTrials.gov ID
- NCT04105881
- Acronym / sponsor ID
- Dear
- Conditions
- Labor, Premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (estimated)
- Primary completion
- 10 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full term labor | – | Dietary Supplement: InvestigationMeasured by flow cytometry and ELUSA |
| Preterm labor | – | Dietary Supplement: InvestigationMeasured by flow cytometry and ELISA |
| Control | – | Dietary Supplement: InvestigationFor comparison |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy term delivery women and preterm labor women
Key inclusion criteria (1 listed)
- healthy female according to the required groups
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InvestigationCross sectional intervention | Dietary supplement | Control, Full term labor, Preterm labor |
Primary outcome
Changes in number of B regulatory cell in pregnant woman
Time frame: 9 months
Immune system immunosuppressed to maintain fetus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Results publication: PubMed 30029057Zahran 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.
- Results publication: PubMed 27267973Lima 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.
- Individual participant dataSharing planned: Undecided. Role of immune system in maintenance of pregnancy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helal Hetta, Lecturer contact
khalid Hassanein principal investigator
Microbiology and immunology department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor, Premature, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid Hassanein, Professor (+20109191208, Khaledhassanein70@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in number of B regulatory cell in pregnant woman (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.