- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340249
Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)
February 22, 2023 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Use of a Perinatal Database and Biologic Tissue Bank at the Perinatology Research Branch (PRB)
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 Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
20964
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Child Health and Human Development (NICHD), 9000 Rockville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
- Not listed in protocol - samples only.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Krebs C, Macara LM, Leiser R, Bowman AW, Greer IA, Kingdom JC. Intrauterine growth restriction with absent end-diastolic flow velocity in the umbilical artery is associated with maldevelopment of the placental terminal villous tree. Am J Obstet Gynecol. 1996 Dec;175(6):1534-42. doi: 10.1016/s0002-9378(96)70103-5.
- Baker PN, Krasnow J, Roberts JM, Yeo KT. Elevated serum levels of vascular endothelial growth factor in patients with preeclampsia. Obstet Gynecol. 1995 Nov;86(5):815-21. doi: 10.1016/0029-7844(95)00259-T.
- Torry DS, Wang HS, Wang TH, Caudle MR, Torry RJ. Preeclampsia is associated with reduced serum levels of placenta growth factor. Am J Obstet Gynecol. 1998 Dec;179(6 Pt 1):1539-44. doi: 10.1016/s0002-9378(98)70021-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 1995
Primary Completion (Actual)
September 18, 2007
Study Completion (Actual)
September 18, 2007
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
February 24, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999995040
- OH95-CH-N040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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