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NCT00339235 · ClinicalTrials.gov registry record
Establishment of a Perinatal Database and a Bank of Biological Materials
A clinical trial of Pregnancy and Preterm Birth, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- 30,570
- Enrollment target
- 1
- Study location
NCT00339235: Completed study of Pregnancy and Preterm Birth, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00339235 is a study of Pregnancy and Preterm Birth that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 30,570 participants, above the 713-participant average among 191 other Pregnancy trials with a reported enrollment target (4188% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00339235, a study of Pregnancy and Preterm Birth, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- 30,570 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Data and specimen analysis is ongoing
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)305 total trials
What the finished NCT00339235 record still lists
NCT00339235 is an observational study that tracks outcomes without assigning an intervention. Its 30,570 participants enrollment target places it among the larger protocols in the corpus, above the 713-participant average among 191 other Pregnancy trials with a reported enrollment target (4188% higher).
The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 0 interventions.
NCT00339235 reports a single indexed study location in Michigan.
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.
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 305 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00339235's enrollment target sits among peer trials
30,570 1st of 191 higher than 191 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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