NCT00340249

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,964

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 1995

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2007

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

12.1 years

First QC Date

June 19, 2006

Last Update Submit

February 22, 2023

Conditions

Keywords

PregnancyPreterm BirthPreterm Birth PreventionPrematurityPregnancy Complications

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Not listed in protocol - samples only.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 8987938BACKGROUND
  • 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.

    PMID: 7566855BACKGROUND
  • 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.

    PMID: 9855593BACKGROUND

MeSH Terms

Conditions

Premature BirthPregnancy Complications

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Roberto Romero, M.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

August 22, 1995

Primary Completion

September 18, 2007

Study Completion

September 18, 2007

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations