Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339235
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2006-06-19
Brief Title:
Establishment of a Perinatal Database and a Bank of Biological Materials
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Establishment of a Clinical Perinatal Database and Bank of Biological Materials
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 14000 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
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 14000 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
Detailed Description:
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 14000 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
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 14000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH98-CH-N001 | None | None | None |