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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01201486
Other study ID # SUS-CH1
Secondary ID
Status Completed
Phase N/A
First received September 13, 2010
Last updated April 26, 2016
Start date October 2006
Est. completion date August 2009

Study information

Verified date April 2016
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at a routine fetal scan in the second trimester of pregnancy


Description:

Almost all women in Norway have a routine ultrasound examination in the second trimester, however, the detection rate of heart defect are only around 50%. In this study we use color Doppler at three different levels in the fetal heart; the four chamber view, the outlet of the aorta on on the level of the great arteries.

All heart defects at delivery are recorded and compared with the ultrasound findings.


Recruitment information / eligibility

Status Completed
Enrollment 6781
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Pregnant

- 2nd trimester

Exclusion Criteria:

- Unwilling

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Stavanger University Hospital Stavanger

Sponsors (1)

Lead Sponsor Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Chaoui R, McEwing R. Three cross-sectional planes for fetal color Doppler echocardiography. Ultrasound Obstet Gynecol. 2003 Jan;21(1):81-93. Review. — View Citation

Eggebø TM, Heien C, Berget M, Ellingsen CL. Routine use of color Doppler in fetal heart scanning in a low-risk population. ISRN Obstet Gynecol. 2012;2012:496935. doi: 10.5402/2012/496935. Epub 2012 May 20. — View Citation

Tegnander E, Eik-Nes SH, Johansen OJ, Linker DT. Prenatal detection of heart defects at the routine fetal examination at 18 weeks in a non-selected population. Ultrasound Obstet Gynecol. 1995 Jun;5(6):372-80. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy The number of *fetuses with* heart defects detected by color Doppler in the second trimester was compared to the number of *fetuses with* major heart defects detected at birth. 2nd trimester No
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