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Establishment of a Perinatal Database and a Bank of Biological Materials

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00339235
First received: June 19, 2006
Last updated: June 30, 2017
Last verified: April 7, 2017
  Purpose

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.


Condition
Preterm Labor Preterm Birth Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of a Clinical Perinatal Database and Bank of Biological Materials

Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):

Primary Outcome Measures:
  • 1.Maternal mortality 2.Route of delivery 3.Infection related complications 4.Bleeding, blood loss and transfusion requirements 5.Hypertensive disorders 6.Venous and arterial thrombotic events 7. Any other complications of pregnancy, labor or del... [ Time Frame: Ongoing ]

Secondary Outcome Measures:
  • Birthweight; Perinatal mortality; Congenital anomalies; Intrauterine growth retardation; Respiratory distress syndrome; Chronic pulmonary disease; Intraventricular hemorrhage;Necrotizing enterocolitis; Retinopathy of prematurity [ Time Frame: Ongoing ]
  • Sepsis; Blood transfusions; Days of hospitalization; Long term outcomes including neurodevelopmental outcome [ Time Frame: Ongoing ]

Estimated Enrollment: 43000
Study Start Date: December 15, 1997
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 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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • ELIGIBILITY CRITERIA:

Women who receive care at participating units will be eligible for participation in this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339235

Locations
United States, Michigan
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
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)
  More Information

Publications:
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00339235     History of Changes
Other Study ID Numbers: 999998001
OH98-CH-N001
Study First Received: June 19, 2006
Last Updated: June 30, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Preterm Birth Prevention
Preterm Birth
Pregnancy
Pregnancy Complications

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 19, 2017