The Role of Cytokines in Apparently Normal Pregnancies

NCT01098214 | Withdrawn

• 1 other identifier: 09310
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy

Keywords

Normal pregnancy; Amniotic fluid; Cytokines; Biomarkers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing amniocentesis with an apparently normal pregnancy

You may qualify if:

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

You may not qualify if:

• Any major fetal anomaly

Sponsors & Collaborators

• NYU Langone Health: lead

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.

Study Officials

• Nazeeh Hanna, M.D.

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 21, 2019

Record last verified: 2019-05