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Establishment of a Perinatal Database and a Bank of Biological Materials

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ClinicalTrials.gov Identifier: NCT00339235
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : November 6, 2020
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) )

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 21, 2006
Last Update Posted Date November 6, 2020
Study Start Date January 6, 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: November 19, 2019)
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 ]
Data and specimen analysis is ongoing
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: October 31, 2020)
Birthweight; Perinatal mortality; Congenital anomalies; Intrauterine growth retardation; Respiratory distress syndrome; Chronic pulmonary disease; Intraventricular hemorrhage;Necrotizing enterocolitis; Retinopathy of prematurity [ Time Frame: Ongoing ]
Birthweight; Perinatal mortality; Congenital anomalies; Intrauterine growth retardation; Respiratory distress syndrome; Chronic pulmonary disease; Intraventricular hemorrhage;Necrotizing enterocolitis; Retinopathy of prematurity
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishment of a Perinatal Database and a Bank of Biological Materials
Official Title Establishment of a Clinical Perinatal Database and Bank of Biological Materials
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 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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women attending Detroit Medical Center (DMC) prenatal clinics in Detroit.Non-pregnant women attending DMC clinics are eligible to participate.
Condition
  • Preterm Labor
  • Preterm Birth
  • Pregnancy
Intervention Not Provided
Study Groups/Cohorts
  • Non-pregnant women
    Non-pregnant women aged 18 years and older
  • Pregant women
    Pregnant women aged 18 years and older
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2018)
30570
Original Enrollment
 (submitted: June 19, 2006)
28000
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • ELIGIBILITY CRITERIA:

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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Australia,   Chile,   Italy,   Korea, Republic of
 
Administrative Information
NCT Number NCT00339235
Other Study ID Numbers 999998001
OH98-CH-N001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators Not Provided
Investigators
Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date October 30, 2020