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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00340249
Other study ID # 999995040
Secondary ID OH95-CH-N040
Status Completed
Phase
First received
Last updated
Start date August 22, 1995
Est. completion date September 18, 2007

Study information

Verified date February 2023
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20964
Est. completion date September 18, 2007
Est. primary completion date September 18, 2007
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility - Not listed in protocol - samples only.

Study Design


Locations

Country Name City State
United States National Institute of Child Health and Human Development (NICHD), 9000 Rockville Bethesda Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

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