Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Completed
CT.gov ID
NCT00340249
Collaborator
(none)
20,964
1
145.7
143.8

Study Details

Study Description

Brief Summary

The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20964 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Use of a Perinatal Database and Biologic Tissue Bank at the Perinatology Research Branch (PRB)
    Actual Study Start Date :
    Jul 27, 1995
    Actual Primary Completion Date :
    Sep 18, 2007
    Actual Study Completion Date :
    Sep 18, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      15 Years to 50 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      • Not listed in protocol - samples only.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institute of Child Health and Human Development (NICHD), 9000 Rockville Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

      Investigators

      • Principal Investigator: Roberto Romero, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
      ClinicalTrials.gov Identifier:
      NCT00340249
      Other Study ID Numbers:
      • 999995040
      • OH95-CH-N040
      First Posted:
      Jun 21, 2006
      Last Update Posted:
      Mar 16, 2021
      Last Verified:
      Jul 1, 2017
      Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Mar 16, 2021