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CompletedNCT00340249Updated Feb 24, 2023

Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)

An observational study in Pregnancy, Premature Birth and Prenatal Care, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-02-24.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20,964
Ages
15 Years to 50 Years
Sex
Female
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Study summary

The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

Read the detailed description

The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

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Conditions studied

  • Pregnancy
  • Premature Birth
  • Prenatal Care
  • Preterm Delivery
  • Preterm Birth

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Keywords

  • Pregnancy
  • Preterm Birth
  • Preterm Birth Prevention
  • Prematurity
  • Pregnancy Complications
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 20,964 is above the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

  • Not listed in protocol - samples only.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20,964 participants (actual)
06

Study locations

1 site
  • National Institute of Child Health and Human Development (NICHD), 9000 Rockville
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • Krebs C, Macara LM, Leiser R, Bowman AW, Greer IA, Kingdom JC. Intrauterine growth restriction with absent end-diastolic flow velocity in the umbilical artery is associated with maldevelopment of the placental terminal villous tree. Am J Obstet Gynecol. 1996 Dec;175(6):1534-42. doi: 10.1016/s0002-9378(96)70103-5. PubMed 8987938 ↗
  • Baker PN, Krasnow J, Roberts JM, Yeo KT. Elevated serum levels of vascular endothelial growth factor in patients with preeclampsia. Obstet Gynecol. 1995 Nov;86(5):815-21. doi: 10.1016/0029-7844(95)00259-T. PubMed 7566855 ↗
  • Torry DS, Wang HS, Wang TH, Caudle MR, Torry RJ. Preeclampsia is associated with reduced serum levels of placenta growth factor. Am J Obstet Gynecol. 1998 Dec;179(6 Pt 1):1539-44. doi: 10.1016/s0002-9378(98)70021-3. PubMed 9855593 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00340249
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Jun 21, 2006
Start date
Aug 22, 1995
Primary completion
Sep 18, 2007
Completion
Sep 18, 2007
Last update
Feb 24, 2023

Study contacts

Roberto Romero, M.D.
principal investigator · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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