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Establishment of a Perinatal Database and a Bank of Biological Materials
NCT00339235 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (1)
Michigan
- Hutzel Women's Hospital — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30,570 participants |
| Start Date | 1998-01-06 |
| Est. Completion | 2016-11-22 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)237 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00339235
The ClinicalTrials.gov registry entry for NCT00339235 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30,570 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00339235 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00339235 about?
NCT00339235 is a clinical study titled "Establishment of a Perinatal Database and a 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 N...
What is the current status of trial NCT00339235?
This trial is currently completed. The enrollment target is 30,570 participants. The study started on 1998-01-06. Estimated completion is 2016-11-22.
What conditions does trial NCT00339235 study?
This clinical trial studies the following conditions: Pregnancy, Preterm Birth, Preterm Labor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00339235?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00339235 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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