Establishment of a Perinatal Database and a Bank of Biological Materials



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:2/17/2019
Start Date:January 6, 1998

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Establishment of a Clinical Perinatal Database and Bank of Biological Materials

The aim of this project is to establish a clinical database and a bank of biological
materials which will be used to improve the pathophysiologic understanding of the mechanisms
underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development
Workshop, sponsored by the NIH, recommended that the setting up of "tissue, blood, and
placental banks from human and relevant animal models should be developed to aid in
understanding how prenatal conditions relate to pathological consequences in adult life".

A large observational study in the United States of America, the National Collaborative
Perinatal Project (NCPP), was conducted over 30 years ago (1959-1966) and has yielded a large
amount of useful information. However standards of obstetrical and neonatal care have changed
significantly over the last 30 years. Thus the setting up of a contemporary clinical
perinatal database and bank of biological materials is required. In order to obtain
sufficient data for statistical analysis a large sample size is necessary.

We propose to carry out this project at Sotero del Rio Hospital, Santiago Chile as this
hospital has a delivery rate of approximately 14,000 women per year. Previous research
collaborative efforts between the Sotero del Rio Hospital and the PRB have been carried out
in compliance with NIH research regulations. Sotero del Rio Hospital has had previous
successful negotiations of Single Project Assurances (SPA) with the NIH.

Information will be collected from clinical history taking, physical examination, sonographic
examination and standard laboratory procedures. The bank of biological fluids and tissues
will include maternal blood, umbilical cord plasma, amniotic fluid, maternal urine and
placental tissue. No procedures will be carried out on patients that are not part of standard
of care at Sotero del Rio Hospital....

The aim of this project is to establish a clinical database and a bank of biological
materials which will be used to improve the pathophysiologic understanding of the mechanisms
underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development
Workshop, sponsored by the NIH, recommended that the setting up of "tissue, blood, and
placental banks from human and relevant animal models should be developed to aid in
understanding how prenatal conditions relate to pathological consequences in adult life".

A large observational study in the United States of America, the National Collaborative
Perinatal Project (NCPP), was conducted over 30 years ago (1959-1966) and has yielded a large
amount of useful information. However standards of obstetrical and neonatal care have changed
significantly over the last 30 years. Thus the setting up of a contemporary clinical
perinatal database and bank of biological materials is required. In order to obtain
sufficient data for statistical analysis a large sample size is necessary.

We propose to carry out this project at Sotero del Rio Hospital, Santiago Chile as this
hospital has a delivery rate of approximately 14,000 women per year. Previous research
collaborative efforts between the Sotero del Rio Hospital and the PRB have been carried out
in compliance with NIH research regulations. Sotero del Rio Hospital has had previous
successful negotiations of Single Project Assurances (SPA) with the NIH.

Information will be collected from clinical history taking, physical examination, sonographic
examination and standard laboratory procedures. The bank of biological fluids and tissues
will include maternal blood, umbilical cord plasma, amniotic fluid, maternal urine and
placental tissue. No procedures will be carried out on patients that are not part of standard
of care at Sotero del Rio Hospital.

- ELIGIBILITY CRITERIA:

Women who receive care at participating units will be eligible for participation in this
study.
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Detroit, Michigan 48201
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Detroit, MI
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