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The Role of Cytokines in Apparently Normal Pregnancies

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ClinicalTrials.gov Identifier: NCT01098214
Recruitment Status : Withdrawn (Decided not to pursue study at this time. Resources not available)
First Posted : April 2, 2010
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Nazeeh Hanna, MD, Winthrop University Hospital

Brief Summary:
To provide rigorous, detailed normative data for diagnostics and comparative studies, to determine relationships between cytokine levels (and other biomarkers) and clinical data, and gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester amniotic fluid.

Condition or disease
Pregnancy

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Cytokines (and Other Biomarkers) in Apparently Normal Pregnancies
Study Start Date : April 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011



Biospecimen Retention:   Samples With DNA
Amniotic fluid samples from patients undergoing amniocentesis with an apparently normal pregnancy will have a small aliquot of fluid stored for future analysis, including the cytokine profile, proteomics, metabolomics, etc.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing amniocentesis with an apparently normal pregnancy
Criteria

Inclusion Criteria:

  • Age over 18
  • Pregnancies between 15-25 weeks gestation.
  • Able to provide informed consent.
  • No apparent major sonographic abnormality.

Exclusion Criteria:

  • Any major fetal anomaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098214


Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Nazeeh Hanna, M.D. Winthrop University Hospital

Responsible Party: Nazeeh Hanna, MD, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01098214     History of Changes
Other Study ID Numbers: 09310
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Nazeeh Hanna, MD, Winthrop University Hospital:
Normal pregnancy
Amniotic fluid
Cytokines
Biomarkers