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Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)
This study has been completed.
First Received: June 19, 2006   Last Updated: August 24, 2009   History of Changes
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00340249
  Purpose

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 video-tapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.


Condition
Biological Samples

Study Type: Observational
Official Title: Use of a Perinatal Database and Biologic Tissue Bank at the Perinatology Research Branch (PRB)

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 0
Study Start Date: July 1995
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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 video-tapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

-Not listed in protocol - samples only.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340249

Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 999995040, OH95-CH-N040
Study First Received: June 19, 2006
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00340249     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Premature Rupture of the Membranes (PROM)
Preterm Delivery
In-Utero Fetal Demise
Chorioamnionitis
Spontaneous Abortion

Study placed in the following topic categories:
Rupture
Chorioamnionitis
Abortion, Spontaneous
Premature Birth

ClinicalTrials.gov processed this record on September 11, 2009