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Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

17 oktober 2019 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)
Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppression has been characterized as a global T-cell defect, the observation that the increase in susceptibility is restricted only to specific intracellular bacteria and viruses is consistent with a down regulation of only certain components of the innate immune system. Progress in the treatment and management of infections during pregnancy will require further understanding of the changes to the immune system that occur during pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate immune system that occurs during pregnancy and remains until delivery and that changes in serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this study will evaluate blood samples drawn from pregnant women during early, mid, and late pregnancy and post-partum for changes in the innate immune system and compare them to those of healthy, non-pregnant women. Changes in the cytokine profile and in the lymphocyte and natural killer (NK) cell populations will be identified. A comparison of any observed changes will be made with those previously reported for in vitro and in vivo studies.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppression has been characterized as a global T-cell defect, the observation that the increase in susceptibility is restricted only to specific intracellular bacteria and viruses is consistent with a down regulation of only certain components of the innate immune system. Progress in the treatment and management of infections during pregnancy will require further understanding of the changes to the immune system that occur during pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate immune system that occurs during pregnancy and remains until delivery and that changes in serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this study will evaluate blood samples drawn from pregnant women during early, mid, and late pregnancy and post-partum for changes in the innate immune system and compare them to data on a similar cohort of women of childbearing age from an existing database of healthy, non-pregnant women. Changes in the cytokine profile, gene expression by microarray, and in the lymphocyte and natural killer (NK) cell populations will be identified. We may perform neutrophil analysis. We will evaluate toll-like receptors functionality, and any changes in PBMC throughout pregnancy.

We also plan to evaluate serum cytokine panels, PBMC by flow cytometry, and PBMC for microarray of gene expression, before and after administration of the influenza vaccine in up to 20 of the 40 pregnant subjects. Antibody levels will be measured as well.

A comparison of any observed changes will be made with those previously reported for in vitro and in vivo studies.

Studietype

Observationeel

Inschrijving (Werkelijk)

41

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

  • INCLUSION CRITERIA:

All pregnant study subjects must:

  • Be between the ages of 18-45 years old.
  • Have a positive pregnancy test (urine).
  • Be of an estimated gestational age of between 10 and 20 weeks either by ultrasound or LMP.
  • Have an identified primary care provider for the pregnancy.
  • Be willing to sign the collaborative study consent form from CHI.
  • Be willing to have samples collected and stored for future research and immunological studies
  • Be willing to sign the collaborative study consent form for normal volunteers from CHI

Up to twenty pregnant subjects who agree to receive the seasonal influenza vaccine must:

  • Have no history of allergic reaction to the vaccine or its contents
  • Not have received the vaccine from other providers this flu season
  • Agree to have an additional 20cc of blood drawn at both Day +1 and Day +7 post-vaccine for immune analysis.

EXCLUSION CRITIERIA:

A subject will be excluded if she:

  • Has an identified underlying chronic medical condition that may adversely affect the immune system (e.g., autoimmune, HIV, or hematologic) or the need for immunomodulating medications (e.g., oral steroids) within 30 days prior to conception for a suspected immune disorder. Oral steroid use for any other reason must have been discontinued for at least 30 days prior to participation.
  • Is found to have a Hemoglobin reading of less than 8g/dL.
  • Has any other medical condition which, in the opinion of the Principal Investigator, poses an unacceptable risk to the subject s participation in the study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-control
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
pregnant flu vaccinated
pregnant women that choose to receive the seasonal flu vaccine
pregnant non-flu vaccinated
pregnant women that do not receive the flu vaccine

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples.
Tijdsspanne: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
Changes in lymphocyte and NK cell populations during pregnancy compared to non- pregnant control samples. [Time Frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum]
1st, 2nd, and 3rd trimesters and postpartum and postpartum
Changes in Cytokine profiles during pregnancy
Tijdsspanne: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples
1st, 2nd, and 3rd trimesters and postpartum and postpartum
Functionality of Toll-like receptors and changes in gene expression
Tijdsspanne: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples [Time Frame: 1st, 2nd, and 3rd trimesters and postpartum]
1st, 2nd, and 3rd trimesters and postpartum and postpartum

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functionality of Toll-like receptors and changes in gene expression
Tijdsspanne: Before and after the administration of the influenza vaccine in a subset of pregnant women
Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples, in a subset of pregnant women [Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women]
Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in lymphocyte and INK cell populations
Tijdsspanne: Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in lymphocyte and INK cell populations during pregnancy compared to non-pregnant control samples, in a subset of pregnant women [Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women]
Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in Cytokine profiles
Tijdsspanne: Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples, in a subset of pregnant women [Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women]
Before and after the administration of the influenza vaccine in a subset of pregnant women

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

30 september 2011

Primaire voltooiing

7 december 2022

Studie voltooiing

11 oktober 2019

Studieregistratiedata

Eerst ingediend

11 september 2010

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2010

Eerst geplaatst (Schatting)

14 september 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

17 oktober 2019

Laatst geverifieerd

11 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 100205
  • 10-I-0205

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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